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 (CheckMate 744)
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ClinicalTrials.gov Identifier: NCT02927769 |
Recruitment Status :
Recruiting
First Posted : October 7, 2016
Last Update Posted : June 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin Disease | Biological: Nivolumab Biological: brentuximab vedotin Biological: bendamustine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | 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) |
Actual Study Start Date : | March 27, 2017 |
Estimated Primary Completion Date : | March 27, 2023 |
Estimated Study Completion Date : | March 27, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Nivolumab + brentuximab vedotin |
Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
Biological: brentuximab vedotin Specified Dose on Specified Days |
Experimental: brentuximab vedotin + bendamustine |
Biological: brentuximab vedotin
Specified Dose on Specified Days Biological: bendamustine Specified Dose on Specified Days |
- Event Free Survival (EFS) [ Time Frame: Up to 5 years ]Low Risk Group. Based on blinded independent central review (BICR)
- Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria.
- Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.
- Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]Based on blinded independent central review (BICR)
- Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]Based on the blinded independent central review (BICR)
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]Based on the blinded independent central review (BICR)
- Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]measured by number of patients
- 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 ]Hematology, Chemistry and Urinalysis
- Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]Temperature, Blood Pressure and Heart Rate
- Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]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.
- Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
- Event Free Survival (EFS) [ Time Frame: Up to 5 years ]Low Risk Group. Based on investigator assessments
- Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]Both Risk Groups. Based on investigator assessments
- Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]Both Risk Groups. Based on investigator assessments
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]Both Risk Groups. Based on investigator assessments

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Ages Eligible for Study: | 5 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927769
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT# and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02927769 |
Other Study ID Numbers: |
CA209-744 2016-002347-41 ( EudraCT Number ) |
First Posted: | October 7, 2016 Key Record Dates |
Last Update Posted: | June 11, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Nivolumab Bendamustine Hydrochloride Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |