An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas (CheckMate 436)

• ClinicalTrials.gov Identifier: NCT02581631
• Recruitment Status: Active, not recruiting
• First Posted: October 21, 2015
• Last Update Posted: August 5, 2019
• Sponsor: Bristol-Myers Squibb
• Collaborator: Seattle Genetics, Inc.
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Disease	Biological: Nivolumab; Drug: Brentuximab Vedotin	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 146 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: December 18, 2015
• Estimated Primary Completion Date: March 1, 2020
• Estimated Study Completion Date: March 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nivolumab+Brentuximab Vedotin; Nivolumab+Brentuximab Vedotin dose as specified	Biological: Nivolumab; Drug: Brentuximab Vedotin

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. Tolerability of combination of nivolumab and brentuximab vedotin based on incidence of deaths, AE, SAE, adverse events leading to discontinuation, adverse events leading to dose delay, drug-related adverse events [ Time Frame: Approximately 2.5 years ]
3. Overall Response Rate (ORR) [ Time Frame: 8 months after the last patient receives their first dose ]
   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 :

1. Overall duration of response (DOR) [ Time Frame: 8 months after the last patient receives their first dose ]
   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
2. Complete response rate (CRR) [ Time Frame: 8 months after the last patient receives their first dose ]
   Complete response rate: Defined as the number of subjects with a BOR of CR divided by the number of treated subjects
3. Duration of complete response [ Time Frame: 8 months after the last patient receives their first dose ]
   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
4. Progression-Free Survival (PFS) [ Time Frame: 8 months after the last patient receives their first dose ]
   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
5. Overall Survival (OS) [ Time Frame: 1 year after the first patient receives their first dose ]
   OS is defined as the time from the date of first dose of study drug until the date of death

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

  Show 27 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Seattle Genetics, Inc.

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information  BMS Clinical Trial Patient Recruiting  Investigator Inquiry Form  FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02581631 History of Changes
• Other Study ID Numbers: CA209-436; 2015-003286-28 ( EudraCT Number )
• First Posted: October 21, 2015
• Last Update Posted: August 5, 2019
• Last Verified: August 2019

Additional relevant MeSH terms:

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nivolumab; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs