Trial · NCT02581631

An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

NCT02581631, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2023-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas. Trials, record NCT02581631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02581631

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
NCT number: NCT02581631
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 145 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Non-Hodgkin's Disease
Interventions: Nivolumab, Brentuximab Vedotin
First posted: 2015-10-21
Last updated: 2023-03-07
Other registries' IDs: eudract:2015-003286-28
Results first posted: 2023-03-07

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	From first dose of treatment to 6 weeks after first dose	DLTs are defined as any study drug-related toxicity (brentuximab vedotin or nivolumab) that requires either a dose reduction or delay of more than 7 days of either study drug in Cycle 2 or delays the Cycle 3 Day 1 administration of combined treatment by more than 7 days.
Primary	Safety Analysis - Number of Participant Deaths	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Number of participant Deaths
Primary	Safety Analysis - Number of Participants With Adverse Advents	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Primary	Safety Analysis - Number of Participants With Serious Adverse Events	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * results in death * is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * requires inpatient hospitalization or causes prolongation of existing hospitalization. * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event
Primary	Safety Analysis - Number of Participants With Adverse Events Leading to Discontinuation	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Number of participants with adverse events leading to discontinuation
Primary	Safety Analysis - Number of Participants With Adverse Events Leading to Dose Delay or Reduction	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Number of participants with adverse events leading to dose delay or reduction
Primary	Safety Analysis - Number of Participants With Drug Related Adverse Events	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Number of participants with Drug Related Adverse Events
Primary	Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Percentage of participants with specific thyroid test abnormalities
Primary	Safety Analysis - Percentage of Participants With Liver Test Abnormalities	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	Percentage of participants with specific Liver test abnormalities
Primary	Objective Response Rate (ORR)	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	The percentage of participants with a best overall response (BOR) of CR or PR. DLBCL, PTCL, PMBL \& MGZL complete and partial response are outlined in the Lugano Classification 2014 and Lymphoma Response to Immunomodulatory therapy Criteria. CTCL complete and partial response are defined in The consensus Global Response Score assessment.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	From first dose of treatment to 6 weeks after first dose	DLT evaluable Participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participant Deaths	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in Cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participants With Adverse Advents	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participants With Serious Adverse Events	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participants With Adverse Events Leading to Discontinuation	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participants With Adverse Events Leading to Dose Delay or Reduction	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Number of Participants With Drug Related Adverse Events	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants in cohort B	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants with at least one on treatment TSH measurement	Percentage of Participants	NUMBER
PRIMARY	Safety Analysis - Percentage of Participants With Liver Test Abnormalities	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants	Percentage of Participants	NUMBER
PRIMARY	Objective Response Rate (ORR)	CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months	All Treated Participants	Percentage of participants	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group173

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	Diffuse Large B-cell Lymphoma (DLBCL)	0	Participants
Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	Peripheral T-cell Lymphoma (PTCL)	0	Participants
Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	Cutaneous T-cell Lymphoma (CTCL)	0	Participants
Safety Analysis - Number of Participant Deaths	Diffuse Large B-cell Lymphoma (DLBCL)	24	Participants
Safety Analysis - Number of Participant Deaths	Peripheral T-cell Lymphoma (PTCL)	22	Participants
Safety Analysis - Number of Participant Deaths	Cutaneous T-cell Lymphoma (CTCL)	3	Participants
Safety Analysis - Number of Participant Deaths	Mediastinal Grey Zone Lymphoma (MGZL)	3	Participants
Safety Analysis - Number of Participant Deaths	Primary Mediastinal B-cell Lymphoma (PMBL)	5	Participants
Safety Analysis - Number of Participants With Adverse Advents	Diffuse Large B-cell Lymphoma (DLBCL)	42	Participants
Safety Analysis - Number of Participants With Adverse Advents	Peripheral T-cell Lymphoma (PTCL)	33	Participants

1 to 10 of 173Source ClinicalTrials.gov

See all 173 results by group

Participant flow25

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Diffuse Large B-cell Lymphoma (DLBCL)	42
Overall Study	STARTED	Peripheral T-cell Lymphoma (PTCL)	33
Overall Study	STARTED	Cutaneous T-cell Lymphoma (CTCL)	29
Overall Study	STARTED	Mediastinal Grey Zone Lymphoma (MGZL)	10
Overall Study	STARTED	Primary Mediastinal B-cell Lymphoma (PMBL)	30
Overall Study	Phase 1 DLT Evaluable Participants	Diffuse Large B-cell Lymphoma (DLBCL)	2
Overall Study	Phase 1 DLT Evaluable Participants	Peripheral T-cell Lymphoma (PTCL)	1
Overall Study	Phase 1 DLT Evaluable Participants	Cutaneous T-cell Lymphoma (CTCL)	3
Overall Study	Phase 1 DLT Evaluable Participants	Mediastinal Grey Zone Lymphoma (MGZL)	0
Overall Study	Phase 1 DLT Evaluable Participants	Primary Mediastinal B-cell Lymphoma (PMBL)	0

1 to 10 of 25Source ClinicalTrials.gov

See all 25 participant flow

Adverse events995

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	DLBCL	5	42
other	Anaemia	Blood and lymphatic system disorders	PTCL	10	33
other	Anaemia	Blood and lymphatic system disorders	CTCL	1	29
other	Anaemia	Blood and lymphatic system disorders	MGZL	6	10
other	Anaemia	Blood and lymphatic system disorders	PMBL	3	30
other	Eosinophilia	Blood and lymphatic system disorders	DLBCL	0	42
other	Eosinophilia	Blood and lymphatic system disorders	PTCL	0	33
other	Eosinophilia	Blood and lymphatic system disorders	CTCL	0	29
other	Eosinophilia	Blood and lymphatic system disorders	MGZL	0	10
other	Eosinophilia	Blood and lymphatic system disorders	PMBL	2	30

1 to 10 of 995Source ClinicalTrials.gov

See all 995 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DLBCL	30	42
Total, all-cause mortality	PTCL	26	33
Total, all-cause mortality	CTCL	14	29
Total, all-cause mortality	MGZL	4	10
Total, all-cause mortality	PMBL	8	30
Total, other adverse events	DLBCL	42	42
Total, other adverse events	PTCL	33	33
Total, other adverse events	CTCL	28	29
Total, other adverse events	MGZL	9	10
Total, other adverse events	PMBL	28	30

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31398081	DERIVED	PubMed
37352266	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02581631

GET https://conductscience.org/api/trials/v1/NCT02581631/results?page=2

API reference For AI assistants