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Trial record 1 of 1 for:    DV3-MEL-01
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A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02521870
Recruitment Status : Terminated (A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.)
First Posted : August 13, 2015
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Melanoma
Head Neck Cancer
Interventions Drug: SD-101(1)
Biological: Pembrolizumab
Drug: SD-101(2)
Biological: SD-101(3)
Enrollment 241
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SD-101 1 mg SD-101 2 mg SD-101 4 mg SD-101 8 mg SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Hide Arm/Group Description Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Period Title: Phase 1: Dose Escalation
Started 6 5 5 6 0 0 0 0 0 0 0 0
Completed SD-101 Treatment (up to 11 Doses) 3 3 0 1 0 0 0 0 0 0 0 0
Completed [1] 1 1 1 0 0 0 0 0 0 0 0 0
Not Completed 5 4 4 6 0 0 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             0             0             0
Adverse Event             2             1             0             0             0             0             0             0             0             0             0             0
Progressive Disease             3             2             4             6             0             0             0             0             0             0             0             0
[1]
Completed Pembrolizumab Treatment (up to 35 doses)
Period Title: Phase 2: Dose Expansion
Started 0 0 0 0 57 25 23 9 24 28 23 30
Completed SD-101 Treatment (up to 11 Doses) 0 0 0 0 25 7 3 2 9 5 1 11
Completed SD-101 Treatment Cycle 2 (up to 22 Doses) 0 0 0 0 7 1 0 0 0 0 0 0
Completed [1] 0 0 0 0 5 0 0 0 2 [2] 0 0 0
Not Completed 0 0 0 0 52 25 23 9 22 28 23 30
Reason Not Completed
Withdrawal by Subject             0             0             0             0             5             1             1             0             1             1             2             0
Adverse Event             0             0             0             0             11             2             0             1             5             0             1             0
Progressive Disease             0             0             0             0             22             18             17             7             5             17             17             21
Death             0             0             0             0             1             1             3             1             1             5             2             2
Other             0             0             0             0             10             3             2             0             10             5             1             7
Lost to Follow-up             0             0             0             0             1             0             0             0             0             0             0             0
Non-Compliance with Study Drug             0             0             0             0             2             0             0             0             0             0             0             0
[1]
Completed Pembrolizumab Treatment (up to 35 doses)
[2]
4 participants completed pembrolizumab treatment (up to 35 cycles).
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg Total
Hide Arm/Group Description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.

 Total of all reporting groups
Overall Number of Baseline Participants 45 41 31 30 28 23 23 9 230
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population comprises all participants who received at least one dose of SD-101. Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101, as specified by the statistical analysis plan. Participants who received 1 mg or 4 mg of SD-101 in Phase 1: Dose Escalation of the study are not included in the analysis groups.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  35.6%
18
  43.9%
13
  41.9%
17
  56.7%
16
  57.1%
10
  43.5%
15
  65.2%
4
  44.4%
109
  47.4%
>=65 years
29
  64.4%
23
  56.1%
18
  58.1%
13
  43.3%
12
  42.9%
13
  56.5%
8
  34.8%
5
  55.6%
121
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
66.2  (13.34) 65.3  (12.44) 65.6  (12.99) 62.4  (15.25) 62.6  (10.66) 67.2  (9.59) 61.0  (12.94) 65.2  (12.35) 64.4  (12.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
Female
13
  28.9%
14
  34.1%
10
  32.3%
7
  23.3%
9
  32.1%
2
   8.7%
8
  34.8%
1
  11.1%
64
  27.8%
Male
32
  71.1%
27
  65.9%
21
  67.7%
23
  76.7%
19
  67.9%
21
  91.3%
15
  65.2%
8
  88.9%
166
  72.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
Hispanic or Latino
0
   0.0%
2
   4.9%
1
   3.2%
4
  13.3%
0
   0.0%
0
   0.0%
2
   8.7%
1
  11.1%
10
   4.3%
Not Hispanic or Latino
43
  95.6%
37
  90.2%
28
  90.3%
26
  86.7%
28
 100.0%
22
  95.7%
20
  87.0%
8
  88.9%
212
  92.2%
Unknown or Not Reported
2
   4.4%
2
   4.9%
2
   6.5%
0
   0.0%
0
   0.0%
1
   4.3%
1
   4.3%
0
   0.0%
8
   3.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
White
44
  97.8%
41
 100.0%
30
  96.8%
25
  83.3%
24
  85.7%
20
  87.0%
19
  82.6%
9
 100.0%
212
  92.2%
Black or African American
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.7%
2
   8.7%
0
   0.0%
5
   2.2%
Asian
0
   0.0%
0
   0.0%
1
   3.2%
1
   3.3%
2
   7.1%
1
   4.3%
2
   8.7%
0
   0.0%
7
   3.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
4
  13.3%
2
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
6
   2.6%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
0
28
  62.2%
30
  73.2%
19
  61.3%
16
  53.3%
5
  17.9%
6
  26.1%
4
  17.4%
2
  22.2%
110
  47.8%
1
17
  37.8%
11
  26.8%
12
  38.7%
14
  46.7%
23
  82.1%
17
  73.9%
19
  82.6%
7
  77.8%
120
  52.2%
[1]
Measure Description:

ECOG PS = Eastern Cooperative Oncology Group Performance Status; 0 = Fully active, able to carry on all pre-disease performance without restriction (better outcome)

1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work (worse outcome)
PDL1 Expression  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 41 participants 31 participants 30 participants 28 participants 23 participants 23 participants 9 participants 230 participants
Positive
21
  46.7%
13
  31.7%
9
  29.0%
13
  43.3%
14
  50.0%
15
  65.2%
4
  17.4%
7
  77.8%
96
  41.7%
Negative
14
  31.1%
15
  36.6%
8
  25.8%
11
  36.7%
2
   7.1%
4
  17.4%
5
  21.7%
1
  11.1%
60
  26.1%
Unknown
10
  22.2%
13
  31.7%
14
  45.2%
6
  20.0%
12
  42.9%
4
  17.4%
14
  60.9%
1
  11.1%
74
  32.2%
1.Primary Outcome
Title Phase 1 Dose Escalation Only - Number of Participants With DLTs
Hide Description Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population is defined as comprising of participants who received at least 1 dose of SD-101.
Arm/Group Title SD-101 1 mg SD-101 2 mg SD-101 4 mg SD-101 8 mg SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Hide Arm/Group Description:
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Overall Number of Participants Analyzed 6 5 5 6 0 0 0 0 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Hide Description Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame Day 1 through Day 743
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description:

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed 45 41 31 30 28 23 23 9
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
9
  20.0%
4
   9.8%
0
   0.0%
1
   3.3%
2
   7.1%
0
   0.0%
0
   0.0%
1
  11.1%
Partial Response
25
  55.6%
16
  39.0%
7
  22.6%
3
  10.0%
4
  14.3%
6
  26.1%
2
   8.7%
0
   0.0%
Stable Disease
2
   4.4%
8
  19.5%
8
  25.8%
8
  26.7%
7
  25.0%
5
  21.7%
3
  13.0%
2
  22.2%
Progressive Disease
5
  11.1%
8
  19.5%
12
  38.7%
11
  36.7%
10
  35.7%
9
  39.1%
10
  43.5%
4
  44.4%
Not Evaluable
4
   8.9%
5
  12.2%
4
  12.9%
7
  23.3%
5
  17.9%
3
  13.0%
8
  34.8%
2
  22.2%
3.Secondary Outcome
Title Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group
Hide Description Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame Day 1 through Day 743
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description:

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed 34 20 7 4 6 6 2 1
Mean (Standard Deviation)
Unit of Measure: months
3.2  (1.6) 4.1  (2.96) 5.1  (3.06) 4.3  (2.98) 2.3  (.92) 2.4  (0.87) 2.7  (1.09) 2.1  (0)
4.Secondary Outcome
Title Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group
Hide Description Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame Day 1 through Day 743
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description:

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed 34 20 7 4 6 6 2 1
Mean (Standard Deviation)
Unit of Measure: months
11.1  (6.42) 11.7  (5.96) 4.6  (6.57) 7.6  (7.28) 5.9  (4.93) 6.3  (3.96) 2.1  (0.07) 8.1  (0)
5.Secondary Outcome
Title Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group
Hide Description Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame Day 1 through Day 743
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description:

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed 45 41 31 30 28 23 23 9
Measure Type: Count of Participants
Unit of Measure: Participants
36
  80.0%
28
  68.3%
15
  48.4%
12
  40.0%
13
  46.4%
11
  47.8%
5
  21.7%
3
  33.3%
6.Secondary Outcome
Title Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
Hide Description Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame Day 1 through Day 743
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description:

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed 45 41 31 30 28 23 23 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3 months
85.7
(70.9 to 93.3)
71.9
(54 to 83.8)
46.7
(28.4 to 63)
48
(27.8 to 65.6)
46.4
(26.6 to 64.1)
43.5
(23.3 to 62.1)
31.6
(12.9 to 52.2)
37.5
(8.7 to 67.4)
6 months
78.4
(62.6 to 88.1)
63.3
(45.2 to 76.8)
33
(17.2 to 49.8)
24
(9.8 to 41.7)
26.5
(10.5 to 45.7)
17.4
(5.4 to 35)
0
(0 to 0)
25
(3.7 to 55.8)
9 months
70.8
(54.3 to 82.3)
60.4
(42.4 to 74.4)
21.4
(8.6 to 37.9)
14.4
(3.9 to 31.4)
21.2
(7.1 to 40.3)
17.4
(5.4 to 35)
0
(0 to 0)
12.5
(0.7 to 42.3)
12 months
70.8
(54.3 to 82.3)
53.7
(35.7 to 68.7)
21.4
(8.6 to 37.9)
9.6
(1.7 to 25.7)
15.9
(4.2 to 34.4)
8.7
(1.5 to 24.2)
00
(0 to 0)
0
(0 to 0)
15 months
65.1
(48.2 to 77.8)
49.9
(31.9 to 65.5)
0
(0 to 0)
9.6
(1.7 to 25.7)
15.9
(4.2 to 34.4)
4.3
(0.3 to 18.2)
00
(0 to 0)
0
(0 to 0)
18 months
61.5
(44 to 75)
40.3
(22.3 to 57.7)
0
(0 to 0)
9.6
(1.7 to 25.7)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
21 months
61.5
(44 to 75)
40.3
(22.3 to 57.7)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
24 months
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Time Frame From informed consent through Day 743
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Hide Arm/Group Description

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7.

Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.

The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
All-Cause Mortality
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/44 (4.55%)   3/39 (7.69%)   5/31 (16.13%)   7/30 (23.33%)   6/27 (22.22%)   13/23 (56.52%)   7/23 (30.43%)   3/9 (33.33%) 
Hide Serious Adverse Events
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/44 (34.09%)   17/39 (43.59%)   6/31 (19.35%)   9/30 (30.00%)   8/27 (29.63%)   5/23 (21.74%)   10/23 (43.48%)   4/9 (44.44%) 
Blood and lymphatic system disorders                 
Anaemia † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Eosinophilia † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Febrile neutropenia † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Iron deficiency anaemia † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Thrombocytopenia † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Cardiac disorders                 
Angina pectoris † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Aortic valve stenosis † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Atrial fibrillation † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Atrial flutter † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Atrioventricular block complete † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Autoimmune myocarditis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Cardiac failure † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Mitral valve stenosis † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pericardial effusion † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Pulseless electrical activity † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Endocrine disorders                 
Hypophysitis † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Eye disorders                 
Autoimmune retinopathy † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders                 
Constipation † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Diarrhoea † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Intussusception † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Lower gastrointestinal haemorrhage † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Mouth haemorrhage † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Nausea † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pancreatitis † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Upper gastrointestinal haemorrhage † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vomiting † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  2/30 (6.67%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
General disorders                 
Asthenia † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Generalised oedema † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Influenza like illness † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Localised oedema † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Oedema peripheral † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pyrexia † 1  1/44 (2.27%)  0/39 (0.00%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Systemic inflammatory response syndrome † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hepatobiliary disorders                 
Autoimmune hepatitis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Bile duct stone † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Immune system disorders                 
Contrast media allergy † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Infections and infestations                 
Abscess † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Cellulitis † 1  2/44 (4.55%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Clostridium difficile colitis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Erysipelas † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Gastroenteritis † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Influenza † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Meningitis aseptic † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Osteomyelitis † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Pneumonia † 1  0/44 (0.00%)  1/39 (2.56%)  1/31 (3.23%)  3/30 (10.00%)  2/27 (7.41%)  1/23 (4.35%)  1/23 (4.35%)  0/9 (0.00%) 
Sepsis † 1  2/44 (4.55%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  1/23 (4.35%)  1/23 (4.35%)  0/9 (0.00%) 
Septic shock † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Skin infection † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Soft tissue infection † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Streptococcal infection † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Urinary tract infection † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Urosepsis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications                 
Cervical vertebral fracture † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Fall † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Humerus fracture † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Infusion related reaction † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Investigations                 
Alanine aminotransferase increased † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Aspartate aminotransferase increased † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Blood creatine phosphokinase increased † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Blood creatinine increased † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders                 
Dehydration † 1  0/44 (0.00%)  3/39 (7.69%)  0/31 (0.00%)  1/30 (3.33%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Failure to thrive † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Fluid overload † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hyponatraemia † 1  0/44 (0.00%)  1/39 (2.56%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Malnutrition † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  2/23 (8.70%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Muscular weakness † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Musculoskeletal chest pain † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Myositis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Basal cell carcinoma † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Infected neoplasm † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Squamous cell carcinoma † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Tumour haemorrhage † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Nervous system disorders                 
Cerebrovascular accident † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Embolic stroke † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Headache † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hepatic encephalopathy † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Ischaemic stroke † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Metabolic encephalopathy † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Myasthenia gravis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Parkinson's disease † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Seizure † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Syncope † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Psychiatric disorders                 
Mental status changes † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Violence-related symptom † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Renal and urinary disorders                 
Acute kidney injury † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Nephrolithiasis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Urinary tract obstruction † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Bronchial hyperreactivity † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Chronic obstructive pulmonary disease † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Cough † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dyspnoea † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Haemoptysis † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypoxia † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pleural effusion † 1  1/44 (2.27%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pneumonia aspiration † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Pneumonitis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pneumothorax † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pulmonary embolism † 1  0/44 (0.00%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Respiratory depression † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Respiratory failure † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders                 
Angioedema † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vascular disorders                 
Aortic aneurysm † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Arterial rupture † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Deep vein thrombosis † 1  0/44 (0.00%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypotension † 1  0/44 (0.00%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Orthostatic hypotension † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA 18_1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/44 (100.00%)   39/39 (100.00%)   31/31 (100.00%)   30/30 (100.00%)   25/27 (92.59%)   23/23 (100.00%)   22/23 (95.65%)   9/9 (100.00%) 
Blood and lymphatic system disorders                 
Anaemia † 1  7/44 (15.91%)  10/39 (25.64%)  4/31 (12.90%)  4/30 (13.33%)  4/27 (14.81%)  5/23 (21.74%)  3/23 (13.04%)  2/9 (22.22%) 
Neutropenia † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Thrombocytopenia † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Cardiac disorders                 
Sinus tachycardia † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Endocrine disorders                 
Hypothyroidism † 1  11/44 (25.00%)  3/39 (7.69%)  1/31 (3.23%)  1/30 (3.33%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Eye disorders                 
Dry eye † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vision blurred † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain † 1  5/44 (11.36%)  4/39 (10.26%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Constipation † 1  8/44 (18.18%)  3/39 (7.69%)  2/31 (6.45%)  6/30 (20.00%)  4/27 (14.81%)  4/23 (17.39%)  0/23 (0.00%)  0/9 (0.00%) 
Diarrhoea † 1  21/44 (47.73%)  11/39 (28.21%)  6/31 (19.35%)  7/30 (23.33%)  2/27 (7.41%)  7/23 (30.43%)  0/23 (0.00%)  0/9 (0.00%) 
Dry mouth † 1  2/44 (4.55%)  3/39 (7.69%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dyspepsia † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dysphagia † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  5/27 (18.52%)  6/23 (26.09%)  0/23 (0.00%)  0/9 (0.00%) 
Nausea † 1  13/44 (29.55%)  15/39 (38.46%)  9/31 (29.03%)  10/30 (33.33%)  8/27 (29.63%)  8/23 (34.78%)  0/23 (0.00%)  0/9 (0.00%) 
Stomatitis † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vomiting † 1  6/44 (13.64%)  6/39 (15.38%)  6/31 (19.35%)  6/30 (20.00%)  5/27 (18.52%)  3/23 (13.04%)  0/23 (0.00%)  0/9 (0.00%) 
General disorders                 
Asthenia † 1  2/44 (4.55%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Chest pain † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Chills † 1  19/44 (43.18%)  20/39 (51.28%)  6/31 (19.35%)  16/30 (53.33%)  3/27 (11.11%)  10/23 (43.48%)  2/23 (8.70%)  1/9 (11.11%) 
Face oedema † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Fatigue † 1  33/44 (75.00%)  31/39 (79.49%)  13/31 (41.94%)  22/30 (73.33%)  15/27 (55.56%)  17/23 (73.91%)  7/23 (30.43%)  5/9 (55.56%) 
Gait disturbance † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Influenza like illness † 1  13/44 (29.55%)  7/39 (17.95%)  10/31 (32.26%)  4/30 (13.33%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Injection site erythema † 1  17/44 (38.64%)  9/39 (23.08%)  4/31 (12.90%)  13/30 (43.33%)  1/27 (3.70%)  4/23 (17.39%)  2/23 (8.70%)  1/9 (11.11%) 
Injection site induration † 1  1/44 (2.27%)  3/39 (7.69%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Injection site pain † 1  11/44 (25.00%)  6/39 (15.38%)  4/31 (12.90%)  8/30 (26.67%)  0/27 (0.00%)  0/23 (0.00%)  2/23 (8.70%)  1/9 (11.11%) 
Injection site pruritus † 1  3/44 (6.82%)  3/39 (7.69%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Injection site reaction † 1  0/44 (0.00%)  0/39 (0.00%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Injection site swelling † 1  9/44 (20.45%)  5/39 (12.82%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  3/23 (13.04%)  1/23 (4.35%)  1/9 (11.11%) 
Malaise † 1  14/44 (31.82%)  20/39 (51.28%)  4/31 (12.90%)  11/30 (36.67%)  0/27 (0.00%)  0/23 (0.00%)  2/23 (8.70%)  2/9 (22.22%) 
Non-cardiac chest pain † 1  2/44 (4.55%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Oedema peripheral † 1  4/44 (9.09%)  5/39 (12.82%)  2/31 (6.45%)  2/30 (6.67%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Pain † 1  5/44 (11.36%)  3/39 (7.69%)  2/31 (6.45%)  2/30 (6.67%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Pyrexia † 1  10/44 (22.73%)  15/39 (38.46%)  7/31 (22.58%)  7/30 (23.33%)  6/27 (22.22%)  6/23 (26.09%)  6/23 (26.09%)  4/9 (44.44%) 
Secretion discharge † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  1/9 (11.11%) 
Infections and infestations                 
Candida infection † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Cellulitis † 1  5/44 (11.36%)  3/39 (7.69%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Folliculitis † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Gastroenteritis viral † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Lower respiratory tract infection † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Nasopharyngitis † 1  1/44 (2.27%)  1/39 (2.56%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Oral candidiasis † 1  3/44 (6.82%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Pneumonia † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Sinusitis † 1  2/44 (4.55%)  2/39 (5.13%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Skin infection † 1  3/44 (6.82%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection † 1  5/44 (11.36%)  3/39 (7.69%)  1/31 (3.23%)  1/30 (3.33%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Urinary tract infection † 1  4/44 (9.09%)  3/39 (7.69%)  2/31 (6.45%)  3/30 (10.00%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications                 
Fall † 1  1/44 (2.27%)  5/39 (12.82%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Investigations                 
Alanine aminotransferase increased † 1  4/44 (9.09%)  2/39 (5.13%)  1/31 (3.23%)  2/30 (6.67%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Aspartate aminotransferase increased † 1  6/44 (13.64%)  5/39 (12.82%)  2/31 (6.45%)  4/30 (13.33%)  2/27 (7.41%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Blood alkaline phosphatase increased † 1  3/44 (6.82%)  2/39 (5.13%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Blood bilirubin increased † 1  1/44 (2.27%)  5/39 (12.82%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Blood creatinine increased † 1  7/44 (15.91%)  8/39 (20.51%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Blood lactate dehydrogenase increased † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
C-reactive protein increased † 1  0/44 (0.00%)  0/39 (0.00%)  3/31 (9.68%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Lymphocyte count decreased † 1  1/44 (2.27%)  3/39 (7.69%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Neutrophil count decreased † 1  2/44 (4.55%)  2/39 (5.13%)  1/31 (3.23%)  3/30 (10.00%)  2/27 (7.41%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Platelet count decreased † 1  3/44 (6.82%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Tri-iodothyronine free decreased † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Weight decreased † 1  3/44 (6.82%)  4/39 (10.26%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
White blood cell count decreased † 1  3/44 (6.82%)  5/39 (12.82%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders                 
Decreased appetite † 1  11/44 (25.00%)  11/39 (28.21%)  3/31 (9.68%)  9/30 (30.00%)  3/27 (11.11%)  3/23 (13.04%)  0/23 (0.00%)  0/9 (0.00%) 
Dehydration † 1  4/44 (9.09%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Hypercalcaemia † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Hyperglycaemia † 1  2/44 (4.55%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hyperkalaemia † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypoalbuminaemia † 1  2/44 (4.55%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypokalaemia † 1  2/44 (4.55%)  4/39 (10.26%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypomagnesaemia † 1  2/44 (4.55%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Hyponatraemia † 1  5/44 (11.36%)  3/39 (7.69%)  1/31 (3.23%)  2/30 (6.67%)  3/27 (11.11%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Increased appetite † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Malnutrition † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia † 1  16/44 (36.36%)  8/39 (20.51%)  3/31 (9.68%)  4/30 (13.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Back pain † 1  4/44 (9.09%)  2/39 (5.13%)  2/31 (6.45%)  3/30 (10.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Groin pain † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Joint swelling † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Muscular weakness † 1  2/44 (4.55%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Musculoskeletal pain † 1  2/44 (4.55%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Myalgia † 1  18/44 (40.91%)  17/39 (43.59%)  2/31 (6.45%)  16/30 (53.33%)  1/27 (3.70%)  9/23 (39.13%)  1/23 (4.35%)  2/9 (22.22%) 
Neck pain † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  2/23 (8.70%)  2/9 (22.22%) 
Pain in extremity † 1  4/44 (9.09%)  4/39 (10.26%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Tumour haemorrhage † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  1/9 (11.11%) 
Tumour pain † 1  3/44 (6.82%)  1/39 (2.56%)  4/31 (12.90%)  2/30 (6.67%)  4/27 (14.81%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Nervous system disorders                 
Dizziness † 1  7/44 (15.91%)  5/39 (12.82%)  3/31 (9.68%)  4/30 (13.33%)  5/27 (18.52%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Dysaesthesia † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dysgeusia † 1  2/44 (4.55%)  1/39 (2.56%)  1/31 (3.23%)  2/30 (6.67%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Headache † 1  23/44 (52.27%)  25/39 (64.10%)  9/31 (29.03%)  14/30 (46.67%)  3/27 (11.11%)  10/23 (43.48%)  2/23 (8.70%)  4/9 (44.44%) 
Hypoaesthesia † 1  2/44 (4.55%)  1/39 (2.56%)  1/31 (3.23%)  2/30 (6.67%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  1/9 (11.11%) 
Memory impairment † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Paraesthesia † 1  1/44 (2.27%)  2/39 (5.13%)  2/31 (6.45%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Peripheral sensory neuropathy † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Presyncope † 1  2/44 (4.55%)  3/39 (7.69%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Sinus headache † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Somnolence † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Syncope † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Tremor † 1  1/44 (2.27%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Psychiatric disorders                 
Anxiety † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  3/23 (13.04%)  1/23 (4.35%)  2/9 (22.22%) 
Insomnia † 1  4/44 (9.09%)  4/39 (10.26%)  3/31 (9.68%)  1/30 (3.33%)  3/27 (11.11%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders                 
Proteinuria † 1  1/44 (2.27%)  3/39 (7.69%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough † 1  8/44 (18.18%)  4/39 (10.26%)  3/31 (9.68%)  6/30 (20.00%)  3/27 (11.11%)  2/23 (8.70%)  1/23 (4.35%)  2/9 (22.22%) 
Dysphonia † 1  1/44 (2.27%)  1/39 (2.56%)  1/31 (3.23%)  1/30 (3.33%)  2/27 (7.41%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Dyspnoea † 1  5/44 (11.36%)  9/39 (23.08%)  6/31 (19.35%)  4/30 (13.33%)  0/27 (0.00%)  0/23 (0.00%)  2/23 (8.70%)  1/9 (11.11%) 
Epistaxis † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Haemoptysis † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Nasal congestion † 1  1/44 (2.27%)  1/39 (2.56%)  2/31 (6.45%)  3/30 (10.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Oropharyngeal pain † 1  4/44 (9.09%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Pleural effusion † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Pneumonia aspiration † 1  0/44 (0.00%)  0/39 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/27 (3.70%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Pneumonitis † 1  2/44 (4.55%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Productive cough † 1  3/44 (6.82%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  1/9 (11.11%) 
Sinus congestion † 1  3/44 (6.82%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders                 
Alopecia † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dermatitis † 1  1/44 (2.27%)  1/39 (2.56%)  1/31 (3.23%)  2/30 (6.67%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dermatitis acneiform † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Dry skin † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Ecchymosis † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Erythema † 1  5/44 (11.36%)  3/39 (7.69%)  4/31 (12.90%)  3/30 (10.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hyperhidrosis † 1  3/44 (6.82%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Night sweats † 1  0/44 (0.00%)  0/39 (0.00%)  1/31 (3.23%)  2/30 (6.67%)  0/27 (0.00%)  0/23 (0.00%)  1/23 (4.35%)  1/9 (11.11%) 
Pruritus † 1  14/44 (31.82%)  6/39 (15.38%)  3/31 (9.68%)  7/30 (23.33%)  2/27 (7.41%)  4/23 (17.39%)  0/23 (0.00%)  0/9 (0.00%) 
Rash † 1  11/44 (25.00%)  7/39 (17.95%)  1/31 (3.23%)  1/30 (3.33%)  2/27 (7.41%)  1/23 (4.35%)  0/23 (0.00%)  0/9 (0.00%) 
Rash erythematous † 1  1/44 (2.27%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Rash maculo-papular † 1  5/44 (11.36%)  5/39 (12.82%)  3/31 (9.68%)  3/30 (10.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Rash pruritic † 1  3/44 (6.82%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Scab † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Skin hypopigmentation † 1  1/44 (2.27%)  3/39 (7.69%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Skin lesion † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vitiligo † 1  5/44 (11.36%)  4/39 (10.26%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Vascular disorders                 
Flushing † 1  2/44 (4.55%)  2/39 (5.13%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Haematoma † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
Hypertension † 1  4/44 (9.09%)  13/39 (33.33%)  1/31 (3.23%)  2/30 (6.67%)  1/27 (3.70%)  2/23 (8.70%)  0/23 (0.00%)  0/9 (0.00%) 
Hypotension † 1  1/44 (2.27%)  1/39 (2.56%)  0/31 (0.00%)  0/30 (0.00%)  2/27 (7.41%)  1/23 (4.35%)  1/23 (4.35%)  1/9 (11.11%) 
Lymphoedema † 1  2/44 (4.55%)  1/39 (2.56%)  3/31 (9.68%)  1/30 (3.33%)  0/27 (0.00%)  0/23 (0.00%)  0/23 (0.00%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA 18_1
†
Indicates events were collected by systematic assessment
The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Janssen MD \ VP & Chief Medical Officer
Organization: Dynavax Technologies, Inc.
Phone: 510-665-0414
EMail: rjanssen@dynavax.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02521870    
Other Study ID Numbers: DV3-MEL-01
Keynote 184 ( Other Identifier: Merck )
SYNERGY-001 ( Other Identifier: Dynavax )
First Submitted: July 30, 2015
First Posted: August 13, 2015
Results First Submitted: April 30, 2021
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021