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Clinical Trial Details

Geo Regions

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Hematological Malignancies

Brentuximab vedotin

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)
Phase 2
NCT02927769

Active Not-enrolling

Globe
Locations

United States, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom

Study design

Participant Group/Arm

EXPERIMENTAL: Nivolumab + brentuximab vedotin

Intervention/Treatment

BIOLOGICAL: Nivolumab

Specified Dose on Specified Days

BIOLOGICAL: brentuximab vedotin

Specified Dose on Specified Days

Participant Group/Arm

EXPERIMENTAL: brentuximab vedotin + bendamustine

Intervention/Treatment

BIOLOGICAL: brentuximab vedotin

Specified Dose on Specified Days

BIOLOGICAL: bendamustine

Specified Dose on Specified Days

Key eligibility criteria

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 apply

Key dates

Study start date
  • March 2017
Estimated primary completion date
  • November 2024

Key endpoints

Primary Outcome Measures
Outcome Measure

Event Free Survival (EFS)

Measure Description

Low Risk Group. Based on blinded independent central review (BICR)

Time Frame

Up to 5 years

Outcome Measure

Complete Metabolic Response (CMR) rate prior to HDCT/ASCT

Measure Description

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.

Time Frame

Up to 5 years

Outcome Measure

Complete Metabolic Response (CMR) rate at any time prior to radiation therapy

Measure Description

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.

Time Frame

Up to 5 years

Secondary Outcome Measures:
Outcome Measure

Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment

Measure Description

Based on blinded independent central review (BICR)

Time Frame

Up to 12 weeks

Outcome Measure

Progression Free Survival Rate (PFSR)

Measure Description

Based on the blinded independent central review (BICR)

Time Frame

Up to 5 years

Outcome Measure

Duration of Response (DOR)

Measure Description

Based on the blinded independent central review (BICR)

Time Frame

Up to 5 years

Outcome Measure

Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.

Measure Description

measured by number of patients

Time Frame

Up to 5 years

Outcome Measure

Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination.

Measure Description

Hematology, Chemistry and Urinalysis

Time Frame

Up to 5 years

Outcome Measure

Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.

Measure Description

Temperature, Blood Pressure and Heart Rate

Time Frame

Up to 5 years

Outcome Measure

Complete Metabolic Response (CMR) rate prior to HDCT/ASCT

Measure 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.

Time Frame

Up to 5 years

Outcome Measure

Complete Metabolic Response (CMR) rate at any time prior to radiation therapy

Measure Description

Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.

Time Frame

Up to 5 years

Outcome Measure

Event Free Survival (EFS)

Measure Description

Low Risk Group. Based on investigator assessments

Time Frame

Up to 5 years

Outcome Measure

Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment

Measure Description

Both Risk Groups. Based on investigator assessments

Time Frame

Up to 12 weeks

Outcome Measure

Progression Free Survival Rate (PFSR)

Measure Description

Both Risk Groups. Based on investigator assessments

Time Frame

Up to 5 years

Outcome Measure

Duration of Response (DOR)

Measure Description

Both Risk Groups. Based on investigator assessments

Time Frame

Up to 5 years

Number of participants

72

Collaborators and investigators

Sponsor: Bristol-Myers Squibb

Collaborator: Seagen Inc.

This information is current as of April 10th 2024.