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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1University of Alabama At BirminghamBirminghamAlabamaUnited States35294-3300
2University Of Miami Sylvester Comprehensive Cancer CenterMiamiFloridaUnited States33136
3Moffitt Cancer CenterTampaFloridaUnited States33612
4Winship Cancer Institute.AtlantaGeorgiaUnited States30322
5University Of ChicagoChicagoIllinoisUnited States60637
6Mayo ClinicRochesterMinnesotaUnited States55905
7Washington University School Of MedicineSaint LouisMissouriUnited States63110
8Icahn School Of Medicine At Mount SinaiNew YorkNew YorkUnited States10029
9Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
10University Of RochesterRochesterNew YorkUnited States14642
11Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
12The Ohio State University Comprehensive Cancer CenterColumbusOhioUnited States43210
13Stephenson Cancer CenterOklahoma CityOklahomaUnited States73104
14Providence Portland Medical CenterPortlandOregonUnited States97213
15Bon Secours-St Francis HospGreenvilleSouth CarolinaUnited States29607
16U of Washington / Seattle Cancer Care AllianceSeattleWashingtonUnited States98109-1023
17BC Cancer Agency - Vancouver CentreVancouverBritish ColumbiaCanadaV5Z 4E6
18Princess Margaret Cancer CentreTorontoOntarioCanadaM5G 2M9
19Jewish General HospitalMontrealQuebecCanadaH3T 1E2
20Hopital Saint LouisParisFrance75010
21Centre Hospitalier Lyon SudPierre Benite CedexFrance69495
22Azienda Ospedaliera Papa Giovanni XxiiiBergamoItaly
23Alma Mater Studiorum - Universita' Di BolognaBolognaItaly40126
24Istituto Clinico HumanitasRozzano (milano)Italy20089
25Hospital Duran I ReynalsHospitalet de Llobregat - BarcelonaSpain08908
26Churchill HospitalOxfordOxfordshireUnited KingdomOX3 7LJ
27Royal Marsden HospitalSuttonSurreyUnited KingdomSM2 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:

Study Results

No Results Posted as of Mar 24, 2020