The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
EXPERIMENTAL: Nivolumab + brentuximab vedotin
BIOLOGICAL: Nivolumab
Specified Dose on Specified Days
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
Other protocol defined inclusion/exclusion criteria apply
Event Free Survival (EFS)
Low Risk Group. Based on blinded independent central review (BICR)
Up to 5 years
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
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.
Up to 5 years
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
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.
Up to 5 years
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Based on blinded independent central review (BICR)
Up to 12 weeks
Progression Free Survival Rate (PFSR)
Based on the blinded independent central review (BICR)
Up to 5 years
Duration of Response (DOR)
Based on the blinded independent central review (BICR)
Up to 5 years
Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.
measured by number of patients
Up to 5 years
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination.
Hematology, Chemistry and Urinalysis
Up to 5 years
Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.
Temperature, Blood Pressure and Heart Rate
Up to 5 years
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
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.
Up to 5 years
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Up to 5 years
Event Free Survival (EFS)
Low Risk Group. Based on investigator assessments
Up to 5 years
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Both Risk Groups. Based on investigator assessments
Up to 12 weeks
Progression Free Survival Rate (PFSR)
Both Risk Groups. Based on investigator assessments
Up to 5 years
Duration of Response (DOR)
Both Risk Groups. Based on investigator assessments
Up to 5 years
72
Sponsor: Bristol-Myers Squibb
Collaborator: Seagen Inc.
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT02927769
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