Relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Opdivo (100 mg/10 ml)
Product Name: NIVOLUMAB - 10ml vial - CLINICAL
Product Code: BMS-936558
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 28 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - R1 (Low Risk) Cohort: To describe event-free survival (EFS) rate at 3 years, as assessed by blinded independent central review (BICR). - R2 (Standard Risk) Cohort: to describe the complete metabolic response (CMR) rate prior to HDCT/ASCT by BICR, using Lugano 2014 response criteria;Secondary Objective: - To assess overall response rate (ORR) (CMR + partial metabolic response [PMR]) using Lugano 2014 criteria of the low risk and standard risk cohorts following 4 cycles of nivolumab and brentuximab vedotin by BICR - To assess PFS rate at 3 years by BICR using Lugano 2014 criteria - Duration of Response (DOR) will be evaluated for those participants who achieved PMR or CMR by BICR as well as for those participants who achieved CMR by BICR prior to IFRT in the low risk cohort and for those participants who achieved CMR prior to HDCT/ASCT in the standard risk cohort -To evaluate efficacy as assessed by investigators using LUGANO (2014) response criteria. - To describe the toxicity of nivolumab + brentuximab in combination in pediatric and young adult participants with relapsed or refractory classical Hodgkin’s lymphoma (cHL) after failure of first-line treatment.;Primary end point(s): - Event Free Survival (EFS) ; Low Risk Group. Based on blinded independent central review (BICR) - Complete Metabolic Response (CMR) prior to RT; 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. - Complete Metabolic Response (CMR) Rate; 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).;Timepoint(s) of evaluation of this end point: Up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Response Rate (ORR) Based on blinded independent central review (BICR) • Progression Free Survival Rate (PFSR) Based on the blinded independent central review (BICR) • Duration of Response (DOR) 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 • Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. Hematology, Chemistry and Urinalysis • Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. Temperature, Blood Pressure and Heart Rate -Complete Metabolic Response (CMR) -Complete Metabolic Response (CMR) rate at any time prior to radiation therapy -EFS: Low Risk Group. Based on investigator assessments -ORR: All participants, based on investigator assessments, after 4 cycles of nivolumab + brentuximab vedotin treatment -PFSR:All participants, based on investigator assessments -DOR: All participants, based on investigator assessments ;Timepoint(s) of evaluation of this end point: - ORR: Up to 12 weeks - Others: Up to 5 years | — |
Countries
Canada, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed