Trial · NCT02181738

Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)

NCT02181738, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2018-12-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational). Trials, record NCT02181738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02181738

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Trial

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

Title: Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
NCT number: NCT02181738
Status: Completed
Phases: Phase 2
Enrollment: 294 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Hodgkin Disease
Interventions: Nivolumab, Doxorubicin, Vinblastine, Dacarbazine
First posted: 2014-07-04
Last updated: 2023-11-28
Other registries' IDs: eudract:2014-001509-42
Results first posted: 2018-12-11

Source ClinicalTrials.gov

Registered outcomes21

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)	ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Primary	Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D	From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject 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.
Secondary	Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).	DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
Secondary	Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Secondary	Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
Secondary	Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Secondary	Duration of PR Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
Secondary	Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Secondary	Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
Secondary	Treatment Discontinuation Rate in Cohort D	From first dose up until the date of treatment discontinuation (up to approximately 100 months).	Treatment discontinuation rate (TDR) is the number of treated participants who received \<4 doses of monotherapy or \<12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed. Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes22

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)	All treated Cohort A, B and C participants	Percentage of Particpants	NUMBER
PRIMARY	Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D	From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)	All Cohort D participants treated in the monotherapy and combination therapy phases.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).	All treated Cohort A, B and C participants with objective response of CR or PR.	Months	MEDIAN
SECONDARY	Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants	Percentage of Participants	NUMBER
SECONDARY	Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants who had a BOR of CR.	Months	MEDIAN
SECONDARY	Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants	Percentage of Participants	NUMBER
SECONDARY	Duration of PR Based on IRRC Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants who had a BOR of PR.	Months	MEDIAN
SECONDARY	Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants	Percentage of Participants	NUMBER
SECONDARY	Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C	From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)	All treated Cohort A, B and C participants who had a BOR of CR or PR.	Months	MEDIAN
SECONDARY	Treatment Discontinuation Rate in Cohort D	From first dose up until the date of treatment discontinuation (up to approximately 100 months).	All Cohort D participants treated in the monotherapy and combination therapy phases.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 22Source ClinicalTrials.gov

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Results by group90

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

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin		65.1	95% Confidence Interval 52.0 to 76.7	Percentage of Particpants
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant		67.5	95% Confidence Interval 56.1 to 77.6	Percentage of Particpants
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C	Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant		73.0	95% Confidence Interval 63.2 to 81.4	Percentage of Particpants
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	Monotherapy	0		Participants
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	Combination Therapy (receiving AVD or NAVD)	30		Participants
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin		26.18	95% Confidence Interval 15.21 to NA	Months
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant		16.59	95% Confidence Interval 9.26 to 25.72	Months
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C	Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant		18.17	95% Confidence Interval 11.63 to 30.85	Months
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin		31.7	95% Confidence Interval 20.6 to 44.7	Percentage of Participants
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant		13.8	95% Confidence Interval 7.1 to 23.3	Percentage of Participants

1 to 10 of 90Source ClinicalTrials.gov

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Participant flow20

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin	63
Overall Study	STARTED	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant	80
Overall Study	STARTED	Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant	100
Overall Study	STARTED	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	51
Overall Study	N-AVD Combination Therapy Phase	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin	0
Overall Study	N-AVD Combination Therapy Phase	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant	0
Overall Study	N-AVD Combination Therapy Phase	Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant	0
Overall Study	N-AVD Combination Therapy Phase	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	49
Overall Study	N-AVD Combination Therapy Phase	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin	0
Overall Study	N-AVD Combination Therapy Phase	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant	0

1 to 10 of 20Source ClinicalTrials.gov

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Adverse events3,570

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	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg	4	46
other	Anaemia	Blood and lymphatic system disorders	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg	1	9
other	Anaemia	Blood and lymphatic system disorders	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg	1	8
other	Anaemia	Blood and lymphatic system disorders	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg	12	75
other	Anaemia	Blood and lymphatic system disorders	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg	0	3
other	Anaemia	Blood and lymphatic system disorders	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg	0	2
other	Anaemia	Blood and lymphatic system disorders	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg	18	84
other	Anaemia	Blood and lymphatic system disorders	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg	2	13
other	Anaemia	Blood and lymphatic system disorders	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg	0	3
other	Anaemia	Blood and lymphatic system disorders	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	9	51

1 to 10 of 3,570Source ClinicalTrials.gov

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Adverse event totals30

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg	14	46
Total, all-cause mortality	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg	3	9
Total, all-cause mortality	Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg	0	8
Total, all-cause mortality	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg	25	75
Total, all-cause mortality	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg	0	3
Total, all-cause mortality	Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg	0	2
Total, all-cause mortality	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg	31	84
Total, all-cause mortality	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg	4	13
Total, all-cause mortality	Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg	0	3
Total, all-cause mortality	Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)	5	51

1 to 10 of 30Source ClinicalTrials.gov

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Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27451390	DERIVED	PubMed
28439879	DERIVED	PubMed
29394125	DERIVED	PubMed
29584546	DERIVED	PubMed
31112476	DERIVED	PubMed
32778827	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.

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