A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Sponsor
Seagen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02572167
Collaborator
Bristol-Myers Squibb (Industry)
93
13
1
71.7
7.2
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.
There will be 3 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.
Study Design
Study Type:
Interventional
Actual Enrollment
:
93 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
Actual Study Start Date
:
Oct 31, 2015
Actual Primary Completion Date
:
Mar 1, 2018
Actual Study Completion Date
:
Oct 21, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brentuximab Vedotin + Nivolumab Brentuximab vedotin plus nivolumab |
Drug: brentuximab vedotin
1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
Other Names:
Drug: nivolumab
3 mg/kg by intravenous (IV) infusion for up to 4 cycles
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AEs) [Up to 28.9 months]
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.
- Complete Remission Rate [Up to 3.42 months]
Number of patients with complete metabolic response (CMR) at end of treatment
Secondary Outcome Measures
- Objective Response Rate [Up to 3.42 months]
Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
- Duration of Complete Response [Up to approximately 3 years]
- Duration of Objective Response [Up to approximately 3 years]
- Progression-free Survival Post-autologous Stem Cell Transplant [Up to approximately 3 years]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
-
Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
-
Documented history of a cerebral vascular event
-
History of another invasive malignancy that has not been in remission for at least 3 years
-
History of progressive multifocal leukoencephalopathy (PML)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope National Medical Center | Duarte | California | United States | 91010-3000 |
| 2 | Stanford Cancer Center | Stanford | California | United States | 94305 |
| 3 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 4 | Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | United States | 48201 |
| 5 | Mayo Clinic Minnesota | Rochester | Minnesota | United States | 55905 |
| 6 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 7 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-7680 |
| 8 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 9 | Memorial Sloan Kettering Cancer Center - Commack | Commack | New York | United States | 11725 |
| 10 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10021 |
| 11 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 12 | James Cancer Hospital / Ohio State University | Columbus | Ohio | United States | 43210 |
| 13 | Charles A. Sammons Cancer Center / Baylor University Medical Center | Dallas | Texas | United States | 75246 |
Sponsors and Collaborators
- Seagen Inc.
- Bristol-Myers Squibb
Investigators
- Study Director: Faith Galderisi, DO, Seagen Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT02572167
Other Study ID Numbers:
- SGN35-025
First Posted:
Oct 8, 2015
Last Update Posted:
Nov 5, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Seagen Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part 1: Staggered Dose | Part 2: Staggered Dose Expansion | Part 3: Same-day Dose |
|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Part 1: Staggered Dose | Part 2: Staggered Dose Expansion | Part 3: Same-day Dose | Total |
|---|---|---|---|---|
| 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 Participants | 6 | 56 | 31 | 93 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
26.0
|
36.5
|
32.0
|
34.0
|
| Sex: Female, Male (Count of 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) (Count of Participants) | ||||
| Hispanic or Latino |
1
16.7%
|
4
7.1%
|
9
29%
|
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%
|
2
3.6%
|
1
3.2%
|
3
3.2%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
3.2%
|
1
1.1%
|
| Asian |
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%
|
| Black or African American |
0
0%
|
2
3.6%
|
0
0%
|
2
2.2%
|
| White |
6
100%
|
47
83.9%
|
25
80.6%
|
78
83.9%
|
| More than one race |
0
0%
|
3
5.4%
|
2
6.5%
|
5
5.4%
|
| Unknown or Not Reported |
0
0%
|
1
1.8%
|
1
3.2%
|
2
2.2%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of 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%
|
2
6.5%
|
2
2.2%
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AEs) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|
| 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 |
| Measure Participants | 6 | 55 | 30 |
| Any treatment-emergent adverse event (TEAE) |
6
100%
|
55
98.2%
|
30
96.8%
|
| AEs related to brentuximab vedotin only |
5
83.3%
|
41
73.2%
|
15
48.4%
|
| AEs related to nivolumab only |
3
50%
|
20
35.7%
|
13
41.9%
|
| AEs related to both study drugs |
5
83.3%
|
37
66.1%
|
27
87.1%
|
| Any serious adverse event (SAE) |
0
0%
|
16
28.6%
|
5
16.1%
|
| SAEs related to brentuximab vedotin only |
0
0%
|
2
3.6%
|
0
0%
|
| SAE related to nivolumab only |
0
0%
|
4
7.1%
|
0
0%
|
| SAE related to both study drugs |
0
0%
|
5
8.9%
|
4
12.9%
|
| AEs leading to treatment discontinuation |
0
0%
|
1
1.8%
|
1
3.2%
|
| Title | Complete Remission Rate |
|---|---|
| Description | Number of patients with complete metabolic response (CMR) at end of treatment |
| Time Frame | Up to 3.42 months |
Outcome Measure Data
| 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 |
|---|---|---|---|
| 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 |
| Measure Participants | 6 | 54 | 30 |
| Count of Participants [Participants] |
4
66.7%
|
33
58.9%
|
24
77.4%
|
| Title | Objective Response Rate |
|---|---|
| Description | Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR) |
| Time Frame | Up to 3.42 months |
Outcome Measure Data
| 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 |
|---|---|---|---|
| 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 |
| Measure Participants | 6 | 54 | 30 |
| Count of Participants [Participants] |
6
100%
|
43
76.8%
|
28
90.3%
|
| Title | Duration of Complete Response |
|---|---|
| Description | |
| Time Frame | Up to approximately 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Duration of Objective Response |
|---|---|
| Description | |
| Time Frame | Up to approximately 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Progression-free Survival Post-autologous Stem Cell Transplant |
|---|---|
| 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
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| 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 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
Serious Adverse Events |
||||||
| Part 1: Staggered Dose | Part 2: Staggered Dose Expansion | Part 3: Same-day Dose | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 16/56 (28.6%) | 5/31 (16.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 0/6 (0%) | 2/56 (3.6%) | 0/31 (0%) | |||
| Eye disorders | ||||||
| Uveitis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/6 (0%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Nausea | 0/6 (0%) | 2/56 (3.6%) | 0/31 (0%) | |||
| Colitis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Enteritis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Large intestine perforation | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Pancreatitis | 0/6 (0%) | 0/56 (0%) | 1/31 (3.2%) | |||
| General disorders | ||||||
| Pyrexia | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Malaise | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Pain | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Infections and infestations | ||||||
| Pneumonia | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Sepsis | 0/6 (0%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Cellulitis | 0/6 (0%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Clostridium difficile infection | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Necrotising soft tissue infection | 0/6 (0%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Septic shock | 0/6 (0%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Systemic candida | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Patella fracture | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Hypercalcaemia | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Hyponatraemia | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Hypophagia | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Nervous system disorders | ||||||
| Guillain-barre syndrome | 0/6 (0%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumonitis | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Respiratory failure | 0/6 (0%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Organising pneumonia | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Pleural effusion | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash generalised | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Vascular disorders | ||||||
| Deep vein thrombosis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Hypotension | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Jugular vein thrombosis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Vena cava thrombosis | 0/6 (0%) | 1/56 (1.8%) | 0/31 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Part 1: Staggered Dose | Part 2: Staggered Dose Expansion | Part 3: Same-day Dose | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 55/56 (98.2%) | 30/31 (96.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 6/6 (100%) | 29/56 (51.8%) | 20/31 (64.5%) | |||
| Anaemia | 6/6 (100%) | 24/56 (42.9%) | 16/31 (51.6%) | |||
| Neutropenia | 6/6 (100%) | 19/56 (33.9%) | 12/31 (38.7%) | |||
| Febrile neutropenia | 5/6 (83.3%) | 12/56 (21.4%) | 6/31 (19.4%) | |||
| Leukopenia | 0/6 (0%) | 7/56 (12.5%) | 7/31 (22.6%) | |||
| Lymphopenia | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Pancytopenia | 0/6 (0%) | 0/56 (0%) | 3/31 (9.7%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 1/6 (16.7%) | 9/56 (16.1%) | 4/31 (12.9%) | |||
| Palpitations | 0/6 (0%) | 3/56 (5.4%) | 2/31 (6.5%) | |||
| Sinus tachycardia | 0/6 (0%) | 3/56 (5.4%) | 2/31 (6.5%) | |||
| Ear and labyrinth disorders | ||||||
| Ear pain | 0/6 (0%) | 2/56 (3.6%) | 4/31 (12.9%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/6 (0%) | 4/56 (7.1%) | 3/31 (9.7%) | |||
| Hyperthyroidism | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Thyroiditis | 1/6 (16.7%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Eye disorders | ||||||
| Dry eye | 0/6 (0%) | 4/56 (7.1%) | 1/31 (3.2%) | |||
| Vision blurred | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 6/6 (100%) | 41/56 (73.2%) | 28/31 (90.3%) | |||
| Diarrhoea | 5/6 (83.3%) | 32/56 (57.1%) | 22/31 (71%) | |||
| Vomiting | 6/6 (100%) | 25/56 (44.6%) | 18/31 (58.1%) | |||
| Constipation | 3/6 (50%) | 22/56 (39.3%) | 13/31 (41.9%) | |||
| Stomatitis | 4/6 (66.7%) | 19/56 (33.9%) | 12/31 (38.7%) | |||
| Abdominal pain | 1/6 (16.7%) | 14/56 (25%) | 10/31 (32.3%) | |||
| Gastrooesophageal reflux disease | 0/6 (0%) | 12/56 (21.4%) | 3/31 (9.7%) | |||
| Dyspepsia | 1/6 (16.7%) | 9/56 (16.1%) | 1/31 (3.2%) | |||
| Dysphagia | 0/6 (0%) | 10/56 (17.9%) | 1/31 (3.2%) | |||
| Dry mouth | 1/6 (16.7%) | 5/56 (8.9%) | 4/31 (12.9%) | |||
| Abdominal distension | 1/6 (16.7%) | 4/56 (7.1%) | 1/31 (3.2%) | |||
| Abdominal discomfort | 1/6 (16.7%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Oesophagitis | 0/6 (0%) | 5/56 (8.9%) | 0/31 (0%) | |||
| Abdominal pain upper | 0/6 (0%) | 2/56 (3.6%) | 2/31 (6.5%) | |||
| Flatulence | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Proctalgia | 1/6 (16.7%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Pancreatitis | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| General disorders | ||||||
| Fatigue | 6/6 (100%) | 39/56 (69.6%) | 28/31 (90.3%) | |||
| Pyrexia | 2/6 (33.3%) | 24/56 (42.9%) | 16/31 (51.6%) | |||
| Chills | 1/6 (16.7%) | 16/56 (28.6%) | 11/31 (35.5%) | |||
| Chest discomfort | 0/6 (0%) | 9/56 (16.1%) | 5/31 (16.1%) | |||
| Pain | 0/6 (0%) | 5/56 (8.9%) | 9/31 (29%) | |||
| Non-cardiac chest pain | 1/6 (16.7%) | 4/56 (7.1%) | 5/31 (16.1%) | |||
| Oedema peripheral | 1/6 (16.7%) | 7/56 (12.5%) | 1/31 (3.2%) | |||
| Asthenia | 0/6 (0%) | 6/56 (10.7%) | 1/31 (3.2%) | |||
| Puncture site pain | 0/6 (0%) | 2/56 (3.6%) | 3/31 (9.7%) | |||
| Malaise | 0/6 (0%) | 2/56 (3.6%) | 2/31 (6.5%) | |||
| Catheter site pain | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Face oedema | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Catheter site rash | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Immune system disorders | ||||||
| Seasonal allergy | 0/6 (0%) | 5/56 (8.9%) | 2/31 (6.5%) | |||
| Engraftment syndrome | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Hypersensitivity | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Infections and infestations | ||||||
| Upper respiratory tract infection | 1/6 (16.7%) | 7/56 (12.5%) | 5/31 (16.1%) | |||
| Nasopharyngitis | 0/6 (0%) | 2/56 (3.6%) | 3/31 (9.7%) | |||
| Folliculitis | 1/6 (16.7%) | 2/56 (3.6%) | 0/31 (0%) | |||
| Fungal skin infection | 1/6 (16.7%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Oral herpes | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Rash pustular | 1/6 (16.7%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Urinary tract infection | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Herpes simplex | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Lung infection | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Rhinovirus infection | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Infusion related reaction | 3/6 (50%) | 25/56 (44.6%) | 11/31 (35.5%) | |||
| Fall | 0/6 (0%) | 2/56 (3.6%) | 2/31 (6.5%) | |||
| Investigations | ||||||
| Transaminases increased | 1/6 (16.7%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Alanine aminotransferase increased | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Weight decreased | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Aspartate aminotransferase increased | 0/6 (0%) | 2/56 (3.6%) | 2/31 (6.5%) | |||
| Weight increased | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Gamma-glutamyltransferase increased | 0/6 (0%) | 0/56 (0%) | 3/31 (9.7%) | |||
| International normalised ratio increased | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Neutrophil count decreased | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 2/6 (33.3%) | 15/56 (26.8%) | 13/31 (41.9%) | |||
| Hypokalaemia | 1/6 (16.7%) | 10/56 (17.9%) | 10/31 (32.3%) | |||
| Hypophosphataemia | 0/6 (0%) | 8/56 (14.3%) | 3/31 (9.7%) | |||
| Hyperglycaemia | 0/6 (0%) | 5/56 (8.9%) | 2/31 (6.5%) | |||
| Hypomagnesaemia | 0/6 (0%) | 2/56 (3.6%) | 5/31 (16.1%) | |||
| Hypocalcaemia | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Fluid overload | 0/6 (0%) | 5/56 (8.9%) | 0/31 (0%) | |||
| Vitamin D deficiency | 0/6 (0%) | 4/56 (7.1%) | 1/31 (3.2%) | |||
| Dehydration | 0/6 (0%) | 1/56 (1.8%) | 3/31 (9.7%) | |||
| Hyponatraemia | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Hyperlipasaemia | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Hypoalbuminaemia | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Hyperuricaemia | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/6 (16.7%) | 15/56 (26.8%) | 7/31 (22.6%) | |||
| Bone pain | 3/6 (50%) | 9/56 (16.1%) | 7/31 (22.6%) | |||
| Myalgia | 3/6 (50%) | 11/56 (19.6%) | 4/31 (12.9%) | |||
| Back pain | 4/6 (66.7%) | 7/56 (12.5%) | 6/31 (19.4%) | |||
| Muscle spasms | 0/6 (0%) | 6/56 (10.7%) | 1/31 (3.2%) | |||
| Pain in extremity | 0/6 (0%) | 6/56 (10.7%) | 1/31 (3.2%) | |||
| Neck pain | 1/6 (16.7%) | 2/56 (3.6%) | 1/31 (3.2%) | |||
| Musculoskeletal pain | 1/6 (16.7%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Nervous system disorders | ||||||
| Headache | 3/6 (50%) | 21/56 (37.5%) | 13/31 (41.9%) | |||
| Peripheral sensory neuropathy | 2/6 (33.3%) | 19/56 (33.9%) | 10/31 (32.3%) | |||
| Dizziness | 1/6 (16.7%) | 13/56 (23.2%) | 4/31 (12.9%) | |||
| Paraesthesia | 1/6 (16.7%) | 7/56 (12.5%) | 3/31 (9.7%) | |||
| Dysgeusia | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Presyncope | 0/6 (0%) | 4/56 (7.1%) | 2/31 (6.5%) | |||
| Syncope | 1/6 (16.7%) | 4/56 (7.1%) | 1/31 (3.2%) | |||
| Hypoaesthesia | 0/6 (0%) | 4/56 (7.1%) | 0/31 (0%) | |||
| Somnolence | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Peripheral motor neuropathy | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Product Issues | ||||||
| Thrombosis in device | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 1/6 (16.7%) | 25/56 (44.6%) | 14/31 (45.2%) | |||
| Insomnia | 0/6 (0%) | 14/56 (25%) | 10/31 (32.3%) | |||
| Depression | 1/6 (16.7%) | 7/56 (12.5%) | 4/31 (12.9%) | |||
| Agitation | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 0/6 (0%) | 5/56 (8.9%) | 3/31 (9.7%) | |||
| Haematuria | 0/6 (0%) | 3/56 (5.4%) | 2/31 (6.5%) | |||
| Micturition urgency | 0/6 (0%) | 1/56 (1.8%) | 2/31 (6.5%) | |||
| Polyuria | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Cystitis haemorrhagic | 1/6 (16.7%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Urinary tract pain | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Vaginal haemorrhage | 1/6 (16.7%) | 1/56 (1.8%) | 1/31 (3.2%) | |||
| Vulvovaginal pruritus | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 1/6 (16.7%) | 20/56 (35.7%) | 10/31 (32.3%) | |||
| Dyspnoea | 2/6 (33.3%) | 15/56 (26.8%) | 8/31 (25.8%) | |||
| Nasal congestion | 1/6 (16.7%) | 13/56 (23.2%) | 1/31 (3.2%) | |||
| Oropharyngeal pain | 2/6 (33.3%) | 4/56 (7.1%) | 5/31 (16.1%) | |||
| Epistaxis | 1/6 (16.7%) | 4/56 (7.1%) | 4/31 (12.9%) | |||
| Hiccups | 1/6 (16.7%) | 7/56 (12.5%) | 1/31 (3.2%) | |||
| Rhinorrhoea | 1/6 (16.7%) | 5/56 (8.9%) | 3/31 (9.7%) | |||
| Throat irritation | 0/6 (0%) | 5/56 (8.9%) | 1/31 (3.2%) | |||
| Pneumonitis | 0/6 (0%) | 2/56 (3.6%) | 3/31 (9.7%) | |||
| Productive cough | 1/6 (16.7%) | 0/56 (0%) | 4/31 (12.9%) | |||
| Asthma | 0/6 (0%) | 2/56 (3.6%) | 2/31 (6.5%) | |||
| Dyspnoea exertional | 1/6 (16.7%) | 2/56 (3.6%) | 1/31 (3.2%) | |||
| Pleural effusion | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Nasal discomfort | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 3/6 (50%) | 28/56 (50%) | 14/31 (45.2%) | |||
| Night sweats | 2/6 (33.3%) | 13/56 (23.2%) | 11/31 (35.5%) | |||
| Rash | 1/6 (16.7%) | 12/56 (21.4%) | 9/31 (29%) | |||
| Rash maculo-papular | 0/6 (0%) | 12/56 (21.4%) | 6/31 (19.4%) | |||
| Rash pruritic | 3/6 (50%) | 10/56 (17.9%) | 5/31 (16.1%) | |||
| Alopecia | 1/6 (16.7%) | 9/56 (16.1%) | 7/31 (22.6%) | |||
| Erythema | 0/6 (0%) | 9/56 (16.1%) | 2/31 (6.5%) | |||
| Urticaria | 1/6 (16.7%) | 6/56 (10.7%) | 4/31 (12.9%) | |||
| Dry skin | 0/6 (0%) | 5/56 (8.9%) | 3/31 (9.7%) | |||
| Pruritus generalised | 3/6 (50%) | 3/56 (5.4%) | 2/31 (6.5%) | |||
| Hyperhidrosis | 0/6 (0%) | 5/56 (8.9%) | 1/31 (3.2%) | |||
| Rash papular | 0/6 (0%) | 2/56 (3.6%) | 3/31 (9.7%) | |||
| Rash erythematous | 1/6 (16.7%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Rash follicular | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Rash generalised | 0/6 (0%) | 3/56 (5.4%) | 1/31 (3.2%) | |||
| Swelling face | 0/6 (0%) | 3/56 (5.4%) | 0/31 (0%) | |||
| Blister | 1/6 (16.7%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Drug eruption | 1/6 (16.7%) | 0/56 (0%) | 1/31 (3.2%) | |||
| Rash morbilliform | 0/6 (0%) | 0/56 (0%) | 2/31 (6.5%) | |||
| Dermatitis contact | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Hyperkeratosis | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
| Vascular disorders | ||||||
| Hypotension | 2/6 (33.3%) | 11/56 (19.6%) | 9/31 (29%) | |||
| Flushing | 1/6 (16.7%) | 10/56 (17.9%) | 3/31 (9.7%) | |||
| Hypertension | 0/6 (0%) | 11/56 (19.6%) | 3/31 (9.7%) | |||
| Hot flush | 2/6 (33.3%) | 5/56 (8.9%) | 4/31 (12.9%) | |||
| Orthostatic hypotension | 0/6 (0%) | 5/56 (8.9%) | 0/31 (0%) | |||
| Deep vein thrombosis | 1/6 (16.7%) | 1/56 (1.8%) | 0/31 (0%) | |||
| Superior vena cava syndrome | 1/6 (16.7%) | 0/56 (0%) | 0/31 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Seattle Genetics, Inc. |
| Phone | (855)473-2436 |
| medinfo@seagen.com |
Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT02572167
Other Study ID Numbers:
- SGN35-025
First Posted:
Oct 8, 2015
Last Update Posted:
Nov 5, 2021
Last Verified:
Nov 1, 2021