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

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ClinicalTrials.gov Identifier: NCT02581631

Recruitment Status : Recruiting

First Posted : October 21, 2015

Last Update Posted : January 23, 2018

See Contacts and Locations

Sponsor:

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 :	June 9, 2019
Estimated Study Completion Date :	February 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Drug Information available for: Brentuximab vedotin Nivolumab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

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 :

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 ]
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 ]
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 :

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
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
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
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
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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581631

Contacts


Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:		Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Show 28 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Seattle Genetics, Inc.

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

BMS Clinical Trial Patient Recruiting This link exits the ClinicalTrials.gov site

Investigator Inquiry Form This link exits the ClinicalTrials.gov site


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 Key Record Dates
Last Update Posted:	January 23, 2018
Last Verified:	January 2018

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 Immunologic Factors Physiological Effects of Drugs

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