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
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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
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Study Type | Interventional |
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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 |
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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)
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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).
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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 | |
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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 | |
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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.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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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%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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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%
|
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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%
|
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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%
|
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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%
|
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[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) |
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PDL1 Expression
Measure Type: Count of Participants Unit of measure: Participants |
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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%
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Name/Title: | Robert Janssen MD \ VP & Chief Medical Officer |
Organization: | Dynavax Technologies, Inc. |
Phone: | 510-665-0414 |
EMail: | rjanssen@dynavax.com |
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 |