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

NCT02581631

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).

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02581631

Trial Eligibility

Document

Title

  • Brief Title:A 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

Trial Conditions

  • Non-Hodgkin's Disease

Trial Interventions

DrugSynonymsArms
NivolumabNivolumab+Brentuximab Vedotin
Brentuximab VedotinNivolumab+Brentuximab Vedotin

Trial Purpose

This is a signaling study to assess whether nivolumab in combination with brentuximab vedotin is safe and effective in certain subtypes of non-hodgkin lymphomas.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Nivolumab+Brentuximab VedotinExperimentalNivolumab+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) and relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS)

- Expression of CD30

- Subjects must be 18 years or older

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:18 Years
Eligible Gender:Both
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:Yes
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:No
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:No
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:No
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:No
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:No
Description:OS is defined as the time from the date of first dose of study drug until the date of death

Trial Keywords