Phase 2
N=72
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
Hodgkin Disease
Bottom Line
View on ClinicalTrials.gov: NCT02927769 ↗Enrolled (actual)
72
Serious AEs
33.3%
Results posted
Feb 2025
Primary outcome: Primary: Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1 — 92.9 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); brentuximab vedotin (Biological); bendamustine (Biological)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1 |
92.9 | — |
| PRIMARY Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1 |
87.5 | — |
| PRIMARY Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2 |
88.6 | — |
| SECONDARY Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR) |
96.4; 93.2 | — |
| SECONDARY Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) |
95.2; 91.1 | — |
| SECONDARY Duration of Response (DOR) by Blinded Independent Centralized Review (BICR) |
NA; NA | — |
| SECONDARY Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1 |
89.3 | — |
| SECONDARY Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1 |
88.5 | — |
| SECONDARY Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2 |
86.4 | — |
| SECONDARY Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator |
100.0; 90.9 | — |
| SECONDARY Progression Free Survival (PFS) Rate at 3 Years by Investigator |
95.8; 88.1 | — |
| SECONDARY Duration of Response (DOR) by Investigator |
NA; NA | — |
| SECONDARY The Number of Participants With Adverse Events (AEs) |
26; 42 | — |
| SECONDARY The Number of Participants With Serious Adverse Events (SAEs) |
8; 9 | — |
| SECONDARY The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests |
6; 8; 5; 4; 1; 0 | — |
| SECONDARY The Number of Participants With Abnormal Laboratory Values for Liver Tests |
8; 5; 3; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Adverse Events |
7; 23; 2; 1; 0; 2 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT02927769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.