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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02581631
Collaborator
Seagen Inc. (Industry)
146
Enrollment
27
Locations
1
Arm
68.4
Anticipated Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
  • Biological: Nivolumab
  • Drug: Brentuximab Vedotin
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
N/A
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 :
Dec 18, 2015
Actual Primary Completion Date :
Jan 16, 2020
Anticipated Study Completion Date :
Aug 30, 2021

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 [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 [Approximately 2.5 years]

  3. Overall Response Rate (ORR) [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) [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) [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 [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) [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) [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

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 University of Alabama At Birmingham Birmingham Alabama United States 35294-3300
2 University Of Miami Sylvester Comprehensive Cancer Center Miami Florida United States 33136
3 Moffitt Cancer Center Tampa Florida United States 33612
4 Winship Cancer Institute. Atlanta Georgia United States 30322
5 University Of Chicago Chicago Illinois United States 60637
6 Mayo Clinic Rochester Minnesota United States 55905
7 Washington University School Of Medicine Saint Louis Missouri United States 63110
8 Icahn School Of Medicine At Mount Sinai New York New York United States 10029
9 Memorial Sloan Kettering Cancer Center New York New York United States 10065
10 University Of Rochester Rochester New York United States 14642
11 Levine Cancer Institute Charlotte North Carolina United States 28204
12 The Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
13 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
14 Providence Portland Medical Center Portland Oregon United States 97213
15 Bon Secours-St Francis Hosp Greenville South Carolina United States 29607
16 U of Washington / Seattle Cancer Care Alliance Seattle Washington United States 98109-1023
17 BC Cancer Agency - Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
18 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
19 Jewish General Hospital Montreal Quebec Canada H3T 1E2
20 Hopital Saint Louis Paris France 75010
21 Centre Hospitalier Lyon Sud Pierre Benite Cedex France 69495
22 Azienda Ospedaliera Papa Giovanni Xxiii Bergamo Italy
23 Alma Mater Studiorum - Universita' Di Bologna Bologna Italy 40126
24 Istituto Clinico Humanitas Rozzano (milano) Italy 20089
25 Hospital Duran I Reynals Hospitalet de Llobregat - Barcelona Spain 08908
26 Churchill Hospital Oxford Oxfordshire United Kingdom OX3 7LJ
27 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT

Sponsors and Collaborators

  • Bristol-Myers Squibb
  • Seagen Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02581631
Other Study ID Numbers:
  • CA209-436
  • 2015-003286-28
First Posted:
Oct 21, 2015
Last Update Posted:
Mar 24, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Nivolumab
Brentuximab Vedotin

Study Results

No Results Posted as of Mar 24, 2020