Description:
The purpose of this study is to determine whether Nivolumab, in combination with brentuximab
vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas
with CD30 expression that have not responded to treatment or have come back. The subtypes we
are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL),
Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and
Mediastinal Gray Zone Lymphoma (MGZL).
Title
- Brief Title: An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
- Official Title: A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination With Brentuximab Vedotin in Subjects With Relapsed Refractory Non Hodgkin Lymphomas With CD30 Expression (CheckMate 436: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 436)
Clinical Trial IDs
- ORG STUDY ID:
CA209-436
- SECONDARY ID:
2015-003286-28
- NCT ID:
NCT02581631
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Nivolumab+Brentuximab Vedotin |
Brentuximab Vedotin | | Nivolumab+Brentuximab Vedotin |
Purpose
The purpose of this study is to determine whether Nivolumab, in combination with brentuximab
vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas
with CD30 expression that have not responded to treatment or have come back. The subtypes we
are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL),
Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and
Mediastinal Gray Zone Lymphoma (MGZL).
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab+Brentuximab Vedotin | Experimental | Nivolumab+Brentuximab Vedotin dose as specified | - Nivolumab
- Brentuximab Vedotin
|
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory
peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell
lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis
fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma
(PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
- Expression of CD30
- Subjects must be 18 years or older (≥ 15 years for PMBL)
Exclusion Criteria:
- Known central nervous system (CNS) lymphomas; Active cerebral/meningeal disease
related to the underlying malignancy
- Active, known, or suspected autoimmune disease
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 15 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety of combination of nivolumab and brentuximab vedotin based on incidence of deaths, adverse events (AE), serious adverse events (SAE), AE leading to discontinuation, AE leading to dose delay, drug-related adverse events |
Time Frame: | Approximately 2.5 years |
Safety Issue: | |
Description: | Overall Response Rate: Defined as the number of subjects with a best overall response (BOR) of confirmed complete remission (CR) or Partial response (PR) divided by the number of treated subjects |
Secondary Outcome Measures
Measure: | Overall duration of response (DOR) |
Time Frame: | 8 months after the last patient receives their first dose |
Safety Issue: | |
Description: | Duration of response: DOR will be calculated from the date of initial documentation of a response (CR, or PR) to the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death |
Measure: | Complete response rate (CRR) |
Time Frame: | 8 months after the last patient receives their first dose |
Safety Issue: | |
Description: | Complete response rate: Defined as the number of subjects with a BOR of CR divided by the number of treated subjects |
Measure: | Duration of complete response |
Time Frame: | 8 months after the last patient receives their first dose |
Safety Issue: | |
Description: | The duration of CR will only be evaluated in subjects with BOR of CR and is defined as the time from first documentation of CR to the date of initial documented progression or death due to any cause, whichever occurs first |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | 8 months after the last patient receives their first dose |
Safety Issue: | |
Description: | PFS is defined as the time from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever comes first |
Measure: | Overall Survival (OS) |
Time Frame: | 1 year after the first patient receives their first dose |
Safety Issue: | |
Description: | OS is defined as the time from the date of first dose of study drug until the date of death |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
March 24, 2020