Description:
The purpose of this study is to determine whether an investigational immuno-therapy
combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
participants of this trial will comprise of patients who have relapsed or did not respond to
treatment and are not eligible for stem cell transplant
Title
- Brief Title: A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
- Official Title: Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Clinical Trial IDs
- ORG STUDY ID:
CA209-812
- SECONDARY ID:
2017-000847-41
- NCT ID:
NCT03138499
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Module A |
Brentuximab vedotin | Adcetris | Module A |
Purpose
The purpose of this study is to determine whether an investigational immuno-therapy
combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
participants of this trial will comprise of patients who have relapsed or did not respond to
treatment and are not eligible for stem cell transplant
Trial Arms
Name | Type | Description | Interventions |
---|
Module A | Experimental | Nivolumab combined with Brentuximab | - Nivolumab
- Brentuximab vedotin
|
Module B | Experimental | Brentuximab alone | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who
are relapsed or refractory with one of the following:
I. Autologous stem cell transplant (ASCT) ineligible patients
ii. Patients after failure of ASCT
- Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and
avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan
Exclusion Criteria:
- Known central nervous system lymphoma
- Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)
- Participants with known history of pancreatitis or progressive multifocal
leukoencephalopathy (PML)
Other protocol defined inclusion/exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments |
Secondary Outcome Measures
Measure: | Complete Response Rate (CRR) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To assess objective response rate and duration of response based on BICR |
Measure: | Duration of response (DOR) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To assess duration of response based on BICR |
Measure: | Duration of complete response (DOCR) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To assess duration of complete response based on BICR |
Measure: | Overall Survival (OS) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To assess overall survival of participants treated with nivolumab + BV versus BV |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to four years |
Safety Issue: | |
Description: | To assess PFS based on investigator assessments |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 11, 2020