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A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma

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: NCT02572167
Recruitment Status : Active, not recruiting
First Posted : October 8, 2015
Results First Posted : March 7, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Interventions Drug: brentuximab vedotin
Drug: nivolumab
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Hide Arm/Group Description

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Period Title: Overall Study
Started 6 56 31
Completed 0 0 0
Not Completed 6 56 31
Reason Not Completed
In follow up             6             48             27
Withdrawal by Subject             0             3             1
Lost to Follow-up             0             2             1
Death             0             3             1
Did not meet inclusion criteria             0             0             1
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose Total
Hide Arm/Group Description

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Total of all reporting groups
Overall Number of Baseline Participants 6 56 31 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 56 participants 31 participants 93 participants
26.0
(20 to 37)
36.5
(18 to 69)
32.0
(20 to 66)
34.0
(18 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 31 participants 93 participants
Female
5
  83.3%
27
  48.2%
19
  61.3%
51
  54.8%
Male
1
  16.7%
29
  51.8%
12
  38.7%
42
  45.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 31 participants 93 participants
Hispanic or Latino
1
  16.7%
4
   7.1%
9
  29.0%
14
  15.1%
Not Hispanic or Latino
5
  83.3%
50
  89.3%
21
  67.7%
76
  81.7%
Unknown or Not Reported
0
   0.0%
2
   3.6%
1
   3.2%
3
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 31 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   3.2%
1
   1.1%
Asian
0
   0.0%
3
   5.4%
2
   6.5%
5
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   3.6%
0
   0.0%
2
   2.2%
White
6
 100.0%
47
  83.9%
25
  80.6%
78
  83.9%
More than one race
0
   0.0%
3
   5.4%
2
   6.5%
5
   5.4%
Unknown or Not Reported
0
   0.0%
1
   1.8%
1
   3.2%
2
   2.2%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 31 participants 93 participants
Grade 0
4
  66.7%
35
  62.5%
19
  61.3%
58
  62.4%
Grade 1
2
  33.3%
21
  37.5%
10
  32.3%
33
  35.5%
Unknown
0
   0.0%
0
   0.0%
2
   6.5%
2
   2.2%
[1]
Measure Description: Measure Description: 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 safety reporting period and additional long-term follow up through 28.9 months.
Time Frame Up to 28.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes all patients who receive any amount of brentuximab vedotin or nivolumab.
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Hide Arm/Group Description:

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Overall Number of Participants Analyzed 6 55 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent adverse event (TEAE)
6
 100.0%
55
 100.0%
30
 100.0%
AEs related to brentuximab vedotin only
5
  83.3%
41
  74.5%
15
  50.0%
AEs related to nivolumab only
3
  50.0%
20
  36.4%
13
  43.3%
AEs related to both study drugs
5
  83.3%
37
  67.3%
27
  90.0%
Any serious adverse event (SAE)
0
   0.0%
16
  29.1%
5
  16.7%
SAEs related to brentuximab vedotin only
0
   0.0%
2
   3.6%
0
   0.0%
SAE related to nivolumab only
0
   0.0%
4
   7.3%
0
   0.0%
SAE related to both study drugs
0
   0.0%
5
   9.1%
4
  13.3%
AEs leading to treatment discontinuation
0
   0.0%
1
   1.8%
1
   3.3%
2.Primary Outcome
Title Complete Remission Rate
Hide Description Number of patients with complete metabolic response (CMR) at end of treatment
Time Frame Up to 3.42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Hide Arm/Group Description:

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Overall Number of Participants Analyzed 6 54 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
33
  61.1%
24
  80.0%
3.Secondary Outcome
Title Objective Response Rate
Hide Description Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
Time Frame Up to 3.42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Hide Arm/Group Description:

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Overall Number of Participants Analyzed 6 54 30
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
43
  79.6%
28
  93.3%
4.Secondary Outcome
Title Duration of Complete Response
Hide Description [Not Specified]
Time Frame Up to approximately 3 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Duration of Objective Response
Hide Description [Not Specified]
Time Frame Up to approximately 3 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Progression-free Survival Post-autologous Stem Cell Transplant
Hide Description PFS is defined as the time from the start of study treatment to the first documentation of disease progression or to death, whichever comes first.
Time Frame Up to approximately 3 years
Outcome Measure Data Not Reported
Time Frame Up to 28.9 months
Adverse Event Reporting Description The timeframe includes a 6.01 safety reporting period and additional long-term follow up through 28.9 months.
 
Arm/Group Title Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Hide Arm/Group Description

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Brentuximab vedotin plus nivolumab

brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

All-Cause Mortality
Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   3/56 (5.36%)   1/31 (3.23%) 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   16/56 (28.57%)   5/31 (16.13%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/6 (0.00%)  2/56 (3.57%)  0/31 (0.00%) 
Eye disorders       
Uveitis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/6 (0.00%)  1/56 (1.79%)  1/31 (3.23%) 
Nausea  1  0/6 (0.00%)  2/56 (3.57%)  0/31 (0.00%) 
Colitis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Enteritis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Large intestine perforation  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Pancreatitis  1  0/6 (0.00%)  0/56 (0.00%)  1/31 (3.23%) 
General disorders       
Pyrexia  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Malaise  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Pain  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Infections and infestations       
Pneumonia  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Sepsis  1  0/6 (0.00%)  1/56 (1.79%)  1/31 (3.23%) 
Cellulitis  1  0/6 (0.00%)  0/56 (0.00%)  1/31 (3.23%) 
Clostridium difficile infection  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Necrotising soft tissue infection  1  0/6 (0.00%)  0/56 (0.00%)  1/31 (3.23%) 
Septic shock  1  0/6 (0.00%)  0/56 (0.00%)  1/31 (3.23%) 
Systemic candida  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Injury, poisoning and procedural complications       
Patella fracture  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Hypercalcaemia  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Hyponatraemia  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Hypophagia  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Nervous system disorders       
Guillain-barre syndrome  1  0/6 (0.00%)  0/56 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Respiratory failure  1  0/6 (0.00%)  1/56 (1.79%)  1/31 (3.23%) 
Organising pneumonia  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Pleural effusion  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash generalised  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Hypotension  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Jugular vein thrombosis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
Vena cava thrombosis  1  0/6 (0.00%)  1/56 (1.79%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Staggered Dose Part 2: Staggered Dose Expansion Part 3: Same-day Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   55/56 (98.21%)   30/31 (96.77%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  6/6 (100.00%)  29/56 (51.79%)  20/31 (64.52%) 
Anaemia  1  6/6 (100.00%)  24/56 (42.86%)  16/31 (51.61%) 
Neutropenia  1  6/6 (100.00%)  19/56 (33.93%)  12/31 (38.71%) 
Febrile neutropenia  1  5/6 (83.33%)  12/56 (21.43%)  6/31 (19.35%) 
Leukopenia  1  0/6 (0.00%)  7/56 (12.50%)  7/31 (22.58%) 
Lymphopenia  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Pancytopenia  1  0/6 (0.00%)  0/56 (0.00%)  3/31 (9.68%) 
Cardiac disorders       
Tachycardia  1  1/6 (16.67%)  9/56 (16.07%)  4/31 (12.90%) 
Palpitations  1  0/6 (0.00%)  3/56 (5.36%)  2/31 (6.45%) 
Sinus tachycardia  1  0/6 (0.00%)  3/56 (5.36%)  2/31 (6.45%) 
Ear and labyrinth disorders       
Ear pain  1  0/6 (0.00%)  2/56 (3.57%)  4/31 (12.90%) 
Endocrine disorders       
Hypothyroidism  1  0/6 (0.00%)  4/56 (7.14%)  3/31 (9.68%) 
Hyperthyroidism  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Thyroiditis  1  1/6 (16.67%)  0/56 (0.00%)  1/31 (3.23%) 
Eye disorders       
Dry eye  1  0/6 (0.00%)  4/56 (7.14%)  1/31 (3.23%) 
Vision blurred  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Gastrointestinal disorders       
Nausea  1  6/6 (100.00%)  41/56 (73.21%)  28/31 (90.32%) 
Diarrhoea  1  5/6 (83.33%)  32/56 (57.14%)  22/31 (70.97%) 
Vomiting  1  6/6 (100.00%)  25/56 (44.64%)  18/31 (58.06%) 
Constipation  1  3/6 (50.00%)  22/56 (39.29%)  13/31 (41.94%) 
Stomatitis  1  4/6 (66.67%)  19/56 (33.93%)  12/31 (38.71%) 
Abdominal pain  1  1/6 (16.67%)  14/56 (25.00%)  10/31 (32.26%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  12/56 (21.43%)  3/31 (9.68%) 
Dyspepsia  1  1/6 (16.67%)  9/56 (16.07%)  1/31 (3.23%) 
Dysphagia  1  0/6 (0.00%)  10/56 (17.86%)  1/31 (3.23%) 
Dry mouth  1  1/6 (16.67%)  5/56 (8.93%)  4/31 (12.90%) 
Abdominal distension  1  1/6 (16.67%)  4/56 (7.14%)  1/31 (3.23%) 
Abdominal discomfort  1  1/6 (16.67%)  3/56 (5.36%)  1/31 (3.23%) 
Oesophagitis  1  0/6 (0.00%)  5/56 (8.93%)  0/31 (0.00%) 
Abdominal pain upper  1  0/6 (0.00%)  2/56 (3.57%)  2/31 (6.45%) 
Flatulence  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Proctalgia  1  1/6 (16.67%)  1/56 (1.79%)  1/31 (3.23%) 
Pancreatitis  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
General disorders       
Fatigue  1  6/6 (100.00%)  39/56 (69.64%)  28/31 (90.32%) 
Pyrexia  1  2/6 (33.33%)  24/56 (42.86%)  16/31 (51.61%) 
Chills  1  1/6 (16.67%)  16/56 (28.57%)  11/31 (35.48%) 
Chest discomfort  1  0/6 (0.00%)  9/56 (16.07%)  5/31 (16.13%) 
Pain  1  0/6 (0.00%)  5/56 (8.93%)  9/31 (29.03%) 
Non-cardiac chest pain  1  1/6 (16.67%)  4/56 (7.14%)  5/31 (16.13%) 
Oedema peripheral  1  1/6 (16.67%)  7/56 (12.50%)  1/31 (3.23%) 
Asthenia  1  0/6 (0.00%)  6/56 (10.71%)  1/31 (3.23%) 
Puncture site pain  1  0/6 (0.00%)  2/56 (3.57%)  3/31 (9.68%) 
Malaise  1  0/6 (0.00%)  2/56 (3.57%)  2/31 (6.45%) 
Catheter site pain  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Face oedema  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Catheter site rash  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Immune system disorders       
Seasonal allergy  1  0/6 (0.00%)  5/56 (8.93%)  2/31 (6.45%) 
Engraftment syndrome  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Hypersensitivity  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Infections and infestations       
Upper respiratory tract infection  1  1/6 (16.67%)  7/56 (12.50%)  5/31 (16.13%) 
Nasopharyngitis  1  0/6 (0.00%)  2/56 (3.57%)  3/31 (9.68%) 
Folliculitis  1  1/6 (16.67%)  2/56 (3.57%)  0/31 (0.00%) 
Fungal skin infection  1  1/6 (16.67%)  1/56 (1.79%)  1/31 (3.23%) 
Oral herpes  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Rash pustular  1  1/6 (16.67%)  0/56 (0.00%)  1/31 (3.23%) 
Urinary tract infection  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Herpes simplex  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Lung infection  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Rhinovirus infection  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Injury, poisoning and procedural complications       
Infusion related reaction  1  3/6 (50.00%)  25/56 (44.64%)  11/31 (35.48%) 
Fall  1  0/6 (0.00%)  2/56 (3.57%)  2/31 (6.45%) 
Investigations       
Transaminases increased  1  1/6 (16.67%)  4/56 (7.14%)  2/31 (6.45%) 
Alanine aminotransferase increased  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Weight decreased  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  2/56 (3.57%)  2/31 (6.45%) 
Weight increased  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Gamma-glutamyltransferase increased  1  0/6 (0.00%)  0/56 (0.00%)  3/31 (9.68%) 
International normalised ratio increased  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Neutrophil count decreased  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Metabolism and nutrition disorders       
Decreased appetite  1  2/6 (33.33%)  15/56 (26.79%)  13/31 (41.94%) 
Hypokalaemia  1  1/6 (16.67%)  10/56 (17.86%)  10/31 (32.26%) 
Hypophosphataemia  1  0/6 (0.00%)  8/56 (14.29%)  3/31 (9.68%) 
Hyperglycaemia  1  0/6 (0.00%)  5/56 (8.93%)  2/31 (6.45%) 
Hypomagnesaemia  1  0/6 (0.00%)  2/56 (3.57%)  5/31 (16.13%) 
Hypocalcaemia  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Fluid overload  1  0/6 (0.00%)  5/56 (8.93%)  0/31 (0.00%) 
Vitamin D deficiency  1  0/6 (0.00%)  4/56 (7.14%)  1/31 (3.23%) 
Dehydration  1  0/6 (0.00%)  1/56 (1.79%)  3/31 (9.68%) 
Hyponatraemia  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Hyperlipasaemia  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Hypoalbuminaemia  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Hyperuricaemia  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/6 (16.67%)  15/56 (26.79%)  7/31 (22.58%) 
Bone pain  1  3/6 (50.00%)  9/56 (16.07%)  7/31 (22.58%) 
Myalgia  1  3/6 (50.00%)  11/56 (19.64%)  4/31 (12.90%) 
Back pain  1  4/6 (66.67%)  7/56 (12.50%)  6/31 (19.35%) 
Muscle spasms  1  0/6 (0.00%)  6/56 (10.71%)  1/31 (3.23%) 
Pain in extremity  1  0/6 (0.00%)  6/56 (10.71%)  1/31 (3.23%) 
Neck pain  1  1/6 (16.67%)  2/56 (3.57%)  1/31 (3.23%) 
Musculoskeletal pain  1  1/6 (16.67%)  0/56 (0.00%)  1/31 (3.23%) 
Nervous system disorders       
Headache  1  3/6 (50.00%)  21/56 (37.50%)  13/31 (41.94%) 
Peripheral sensory neuropathy  1  2/6 (33.33%)  19/56 (33.93%)  10/31 (32.26%) 
Dizziness  1  1/6 (16.67%)  13/56 (23.21%)  4/31 (12.90%) 
Paraesthesia  1  1/6 (16.67%)  7/56 (12.50%)  3/31 (9.68%) 
Dysgeusia  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Presyncope  1  0/6 (0.00%)  4/56 (7.14%)  2/31 (6.45%) 
Syncope  1  1/6 (16.67%)  4/56 (7.14%)  1/31 (3.23%) 
Hypoaesthesia  1  0/6 (0.00%)  4/56 (7.14%)  0/31 (0.00%) 
Somnolence  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Peripheral motor neuropathy  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Product Issues       
Thrombosis in device  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Psychiatric disorders       
Anxiety  1  1/6 (16.67%)  25/56 (44.64%)  14/31 (45.16%) 
Insomnia  1  0/6 (0.00%)  14/56 (25.00%)  10/31 (32.26%) 
Depression  1  1/6 (16.67%)  7/56 (12.50%)  4/31 (12.90%) 
Agitation  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Renal and urinary disorders       
Dysuria  1  0/6 (0.00%)  5/56 (8.93%)  3/31 (9.68%) 
Haematuria  1  0/6 (0.00%)  3/56 (5.36%)  2/31 (6.45%) 
Micturition urgency  1  0/6 (0.00%)  1/56 (1.79%)  2/31 (6.45%) 
Polyuria  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Cystitis haemorrhagic  1  1/6 (16.67%)  1/56 (1.79%)  0/31 (0.00%) 
Urinary tract pain  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Reproductive system and breast disorders       
Vaginal haemorrhage  1  1/6 (16.67%)  1/56 (1.79%)  1/31 (3.23%) 
Vulvovaginal pruritus  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/6 (16.67%)  20/56 (35.71%)  10/31 (32.26%) 
Dyspnoea  1  2/6 (33.33%)  15/56 (26.79%)  8/31 (25.81%) 
Nasal congestion  1  1/6 (16.67%)  13/56 (23.21%)  1/31 (3.23%) 
Oropharyngeal pain  1  2/6 (33.33%)  4/56 (7.14%)  5/31 (16.13%) 
Epistaxis  1  1/6 (16.67%)  4/56 (7.14%)  4/31 (12.90%) 
Hiccups  1  1/6 (16.67%)  7/56 (12.50%)  1/31 (3.23%) 
Rhinorrhoea  1  1/6 (16.67%)  5/56 (8.93%)  3/31 (9.68%) 
Throat irritation  1  0/6 (0.00%)  5/56 (8.93%)  1/31 (3.23%) 
Pneumonitis  1  0/6 (0.00%)  2/56 (3.57%)  3/31 (9.68%) 
Productive cough  1  1/6 (16.67%)  0/56 (0.00%)  4/31 (12.90%) 
Asthma  1  0/6 (0.00%)  2/56 (3.57%)  2/31 (6.45%) 
Dyspnoea exertional  1  1/6 (16.67%)  2/56 (3.57%)  1/31 (3.23%) 
Pleural effusion  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Nasal discomfort  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  3/6 (50.00%)  28/56 (50.00%)  14/31 (45.16%) 
Night sweats  1  2/6 (33.33%)  13/56 (23.21%)  11/31 (35.48%) 
Rash  1  1/6 (16.67%)  12/56 (21.43%)  9/31 (29.03%) 
Rash maculo-papular  1  0/6 (0.00%)  12/56 (21.43%)  6/31 (19.35%) 
Rash pruritic  1  3/6 (50.00%)  10/56 (17.86%)  5/31 (16.13%) 
Alopecia  1  1/6 (16.67%)  9/56 (16.07%)  7/31 (22.58%) 
Erythema  1  0/6 (0.00%)  9/56 (16.07%)  2/31 (6.45%) 
Urticaria  1  1/6 (16.67%)  6/56 (10.71%)  4/31 (12.90%) 
Dry skin  1  0/6 (0.00%)  5/56 (8.93%)  3/31 (9.68%) 
Pruritus generalised  1  3/6 (50.00%)  3/56 (5.36%)  2/31 (6.45%) 
Hyperhidrosis  1  0/6 (0.00%)  5/56 (8.93%)  1/31 (3.23%) 
Rash papular  1  0/6 (0.00%)  2/56 (3.57%)  3/31 (9.68%) 
Rash erythematous  1  1/6 (16.67%)  3/56 (5.36%)  0/31 (0.00%) 
Rash follicular  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Rash generalised  1  0/6 (0.00%)  3/56 (5.36%)  1/31 (3.23%) 
Swelling face  1  0/6 (0.00%)  3/56 (5.36%)  0/31 (0.00%) 
Blister  1  1/6 (16.67%)  1/56 (1.79%)  0/31 (0.00%) 
Drug eruption  1  1/6 (16.67%)  0/56 (0.00%)  1/31 (3.23%) 
Rash morbilliform  1  0/6 (0.00%)  0/56 (0.00%)  2/31 (6.45%) 
Dermatitis contact  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Hyperkeratosis  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
Vascular disorders       
Hypotension  1  2/6 (33.33%)  11/56 (19.64%)  9/31 (29.03%) 
Flushing  1  1/6 (16.67%)  10/56 (17.86%)  3/31 (9.68%) 
Hypertension  1  0/6 (0.00%)  11/56 (19.64%)  3/31 (9.68%) 
Hot flush  1  2/6 (33.33%)  5/56 (8.93%)  4/31 (12.90%) 
Orthostatic hypotension  1  0/6 (0.00%)  5/56 (8.93%)  0/31 (0.00%) 
Deep vein thrombosis  1  1/6 (16.67%)  1/56 (1.79%)  0/31 (0.00%) 
Superior vena cava syndrome  1  1/6 (16.67%)  0/56 (0.00%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
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: Chief Medical Officer
Organization: Seattle Genetics, Inc.
Phone: (855)473-2436
EMail: medinfo@seagen.com
Layout table for additonal information
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02572167     History of Changes
Other Study ID Numbers: SGN35-025
First Submitted: October 7, 2015
First Posted: October 8, 2015
Results First Submitted: February 13, 2019
Results First Posted: March 7, 2019
Last Update Posted: October 15, 2019