ConductScience.org, home

Trial ยท NCT02927769

A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment

NCT02927769, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2025-02-10

3 sourcestrials-2026-11-12-0.5.0

Download JSON
Cite this record

ConductScience Library. A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment. Trials, record NCT02927769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02927769

On this page

Trial

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

Title
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
NCT number
NCT02927769
Status
Completed
Phases
Phase 2
Enrollment
72 participants, actual
Lead sponsor
Bristol-Myers Squibb
Conditions
Hodgkin Disease
Interventions
Nivolumab, brentuximab vedotin, bendamustine
First posted
2016-10-07
Last updated
2025-02-10
Other registries' IDs
eudract:2016-002347-41
Results first posted
2025-02-10

Source ClinicalTrials.gov

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryComplete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
PrimaryEvent-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1At 3 years post first dose of study therapy
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
PrimaryComplete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
SecondaryOverall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable.
SecondaryProgression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)At 3 years post first dose of study therapy
Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates.
SecondaryDuration of Response (DOR) by Blinded Independent Centralized Review (BICR)From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)
Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates
SecondaryComplete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
SecondaryEvent-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1At 3 years post first dose of study therapy
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
SecondaryComplete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method.
SecondaryOverall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by InvestigatorFrom first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable.

Outcomes17

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYComplete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.Percent of participantsNUMBER
PRIMARYEvent-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1At 3 years post first dose of study therapyAll treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.Percent of participantsNUMBER
PRIMARYComplete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.Percent of participantsNUMBER
SECONDARYOverall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).All treated participants.Percent of participantsNUMBER
SECONDARYProgression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)At 3 years post first dose of study therapyAll treated participants.Percent of participantsNUMBER
SECONDARYDuration of Response (DOR) by Blinded Independent Centralized Review (BICR)From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).MonthsMEDIAN
SECONDARYComplete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.Percent of participantsNUMBER
SECONDARYEvent-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1At 3 years post first dose of study therapyAll treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.Percent of participantsNUMBER
SECONDARYComplete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.Percent of participantsNUMBER
SECONDARYOverall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by InvestigatorFrom first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).All treated participants.Percent of participantsNUMBER

Results by group68

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

OutcomeGroupCategoryValueSpreadUnits
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse92.990% Confidence Interval 79.2 to 98.7Percent of participants
Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse87.590% Confidence Interval 70.6 to 95.0Percent of participants
Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse88.690% Confidence Interval 77.6 to 95.4Percent of participants
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse96.490% Confidence Interval 84.1 to 99.8Percent of participants
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse93.290% Confidence Interval 83.3 to 98.1Percent of participants
Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse95.290% Confidence Interval 77.7 to 99.1Percent of participants
Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse91.190% Confidence Interval 78.4 to 96.5Percent of participants
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk RelapseNA95% Confidence Interval NA to NAMonths
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk RelapseNA95% Confidence Interval NA to NAMonths
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse89.390% Confidence Interval 74.6 to 97.0Percent of participants

Participant flow18

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

PeriodMilestoneGroupParticipantsUnits counted
Induction PhaseSTARTEDCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse28
Induction PhaseSTARTEDCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse44
Induction PhaseCOMPLETEDCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse27
Induction PhaseCOMPLETEDCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse42
Induction PhaseNOT COMPLETEDCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse1
Induction PhaseNOT COMPLETEDCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse2
Consolidation PhaseSTARTEDCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse22
Consolidation PhaseSTARTEDCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse32
Consolidation PhaseCOMPLETEDCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse22
Consolidation PhaseCOMPLETEDCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse32

Adverse events580

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)122
otherAnaemiaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)16
otherAnaemiaBlood and lymphatic system disordersCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)633
otherAnaemiaBlood and lymphatic system disordersCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)311
otherFebrile neutropeniaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)022
otherFebrile neutropeniaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)06
otherFebrile neutropeniaBlood and lymphatic system disordersCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)533
otherFebrile neutropeniaBlood and lymphatic system disordersCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)411
otherLeukopeniaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)022
otherLeukopeniaBlood and lymphatic system disordersCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)16

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)022
Total, all-cause mortalityCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)06
Total, all-cause mortalityCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)033
Total, all-cause mortalityCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)111
Total, other adverse eventsCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)1822
Total, other adverse eventsCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)66
Total, other adverse eventsCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)3333
Total, other adverse eventsCohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)1111
Total, serious adverse eventsCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)622
Total, serious adverse eventsCohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)36

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
36564047DERIVEDPubMed
39745739DERIVEDPubMed

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 comparisons2

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

ComparisonSource
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse vs Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse: The Number of Participants With Serious Adverse Events (SAEs)
Trial comparisons
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse vs Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse: The Number of Participants With Adverse Events (AEs)
Trial comparisons

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/NCT02927769

GET https://conductscience.org/api/trials/v1/NCT02927769/results?page=2