Description:
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin
(followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is
safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are
children, adolescents, and young adults relapsed or refractory to first line.
Title
- Brief Title: A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
- Official Title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)
Clinical Trial IDs
- ORG STUDY ID:
CA209-744
- SECONDARY ID:
2016-002347-41
- NCT ID:
NCT02927769
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | BMS-936558, Opdivo | Nivolumab + brentuximab vedotin |
| brentuximab vedotin | | Nivolumab + brentuximab vedotin |
| bendamustine | | brentuximab vedotin + bendamustine |
Purpose
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin
(followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is
safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are
children, adolescents, and young adults relapsed or refractory to first line.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab + brentuximab vedotin | Experimental | | - Nivolumab
- brentuximab vedotin
|
| brentuximab vedotin + bendamustine | Experimental | | - brentuximab vedotin
- bendamustine
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Classic Hodgkin Lymphoma (cHL), relapsed or refractory
- Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for
participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.
- One prior anti-cancer therapy that did not work
Exclusion Criteria:
- Active, known, or suspected autoimmune disease or infection
- Active cerebral/meningeal disease related to the underlying malignancy
- More than one line of anti-cancer therapy or no treatment at all
- Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as
checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria could apply
| Maximum Eligible Age: | 30 Years |
| Minimum Eligible Age: | 5 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Event Free Survival (EFS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Low Risk Group. Based on blinded independent central review (BICR) |
Secondary Outcome Measures
| Measure: | Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment |
| Time Frame: | Up to 12 weeks |
| Safety Issue: | |
| Description: | Based on blinded independent central review (BICR) |
| Measure: | Progression Free Survival Rate (PFSR) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Based on the blinded independent central review (BICR) |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Based on the blinded independent central review (BICR) |
| Measure: | Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | measured by number of patients |
| Measure: | Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Hematology, Chemistry and Urinalysis |
| Measure: | Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Temperature, Blood Pressure and Heart Rate |
| Measure: | Complete Metabolic Response (CMR) rate prior to HDCT/ASCT |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria. |
| Measure: | Complete Metabolic Response (CMR) rate at any time prior to radiation therapy |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria. |
| Measure: | Event Free Survival (EFS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Low Risk Group. Based on investigator assessments |
| Measure: | Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment |
| Time Frame: | Up to 12 weeks |
| Safety Issue: | |
| Description: | Both Risk Groups. Based on investigator assessments |
| Measure: | Progression Free Survival Rate (PFSR) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Both Risk Groups. Based on investigator assessments |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Both Risk Groups. Based on investigator assessments |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
June 11, 2020
