Phase IIB Study of Nivolumab in subjects with Hodgkin's Lymphoma (registrational)

Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in classical Hodgkin Lymphoma (cHL) Subjects - CheckMate 205: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 205

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001509-42-AT

Enrollment

340

Registered

2014-06-05

Start date

2014-07-11

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Disease MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C - enrolment closed) - Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D) - Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrolment closed) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Known central nervous system lymphoma - Subjects with nodular lymphocyte-predominant Hodgkin Lymphoma - Prior allogeneic SCT - Chest radiation = 24 weeks prior to first dose - Carmustine = 600 mg/m² received as part of the pre-transplant conditioning regimen

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma subjects; Secondary Objective: Cohorts A, B & C: - Duration of response (DOR) - Complete remission (CR) rate and duration - Partial remission (PR) rate and duration - Investigator-assessed Objective Response Rate and Duration of Response Cohort D: - Treatment discontinuation rate, defined by the number of subjects who were treated with fewer than 12 doses - Treatment discontinuation rate of nivolumab monotherapy - Treatment discontinuation rate of the Nivolumab-AVD combination therapy - Treatment discontinuation rate of the combination therapy - Incidence of treatment related grade 3-5 AEs during the monotherapy phase - Incidence of treatment related grade 3-5 AEs during the combination phase ; Primary end point(s): - Cohorts A, B & C: Number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 International Working Group (IWG) criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects - Cohort D: proportion of subjects who experienced at least one treatment-related Grade 3 - 5 AEs (per NCI CTCAE version 4.0 criteria, any PT term) with an onset date after or on the first dose date and no later than 30 days after the last study dose date, among subjects receiving at least one dose of study treatment ; Timepoint(s) of evaluation of this end point: - Cohorts A, B & C: up to one year after last patient first treatment - Cohort D: approximately 10 months after last cohort D patient first treatment.	—

Measure

Time frame

Main Objective: The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma subjects; Secondary Objective: Cohorts A, B & C: - Duration of response (DOR) - Complete remission (CR) rate and duration - Partial remission (PR) rate and duration - Investigator-assessed Objective Response Rate and Duration of Response Cohort D: - Treatment discontinuation rate, defined by the number of subjects who were treated with fewer than 12 doses - Treatment discontinuation rate of nivolumab monotherapy - Treatment discontinuation rate of the Nivolumab-AVD combination therapy - Treatment discontinuation rate of the combination therapy - Incidence of treatment related grade 3-5 AEs during the monotherapy phase - Incidence of treatment related grade 3-5 AEs during the combination phase ; Primary end point(s): - Cohorts A, B & C: Number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 International Working Group (IWG) criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects - Cohort D: proportion of subjects who experienced at least one treatment-related Grade 3 - 5 AEs (per NCI CTCAE version 4.0 criteria, any PT term) with an onset date after or on the first dose date and no later than 30 days after the last study dose date, among subjects receiving at least one dose of study treatment ; Timepoint(s) of evaluation of this end point: - Cohorts A, B & C: up to one year after last patient first treatment - Cohort D: approximately 10 months after last cohort D patient first treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Cohorts A, B & C: - Duration of response (DOR) - Complete remission (CR) rate and duration - Partial remission (PR) rate and duration - Investigator-assessed Objective Response Rate and Duration of Response Cohort D: -Treatment discontinuation rate, defined by the number of subjects who were treated with fewer than 12 doses -Treatment discontinuation rate of nivolumab monotherapy -Treatment discontinuation rate of the Nivolumab-AVD combination therapy -Treatment discontinuation rate of the combination therapy -Incidence of treatment related grade 3-5 AEs during the monotherapy phase -Incidence of treatment related grade 3-5 AEs during the combination phase ; Timepoint(s) of evaluation of this end point: Cohorts A, B & C: up to one year after last patient first treatment Cohort D: approximately 10 months after last cohort D patient first treatment.	—

Measure

Time frame

Secondary end point(s): Cohorts A, B & C: - Duration of response (DOR) - Complete remission (CR) rate and duration - Partial remission (PR) rate and duration - Investigator-assessed Objective Response Rate and Duration of Response Cohort D: -Treatment discontinuation rate, defined by the number of subjects who were treated with fewer than 12 doses -Treatment discontinuation rate of nivolumab monotherapy -Treatment discontinuation rate of the Nivolumab-AVD combination therapy -Treatment discontinuation rate of the combination therapy -Incidence of treatment related grade 3-5 AEs during the monotherapy phase -Incidence of treatment related grade 3-5 AEs during the combination phase ; Timepoint(s) of evaluation of this end point: Cohorts A, B & C: up to one year after last patient first treatment Cohort D: approximately 10 months after last cohort D patient first treatment.

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Countries

Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026