Phase 2
N=294
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Hodgkin Disease
Bottom Line
View on ClinicalTrials.gov: NCT02181738 ↗Enrolled (actual)
294
Serious AEs
34.4%
Results posted
Dec 2018
Primary outcome: Primary: Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C — 65.1; 67.5; 73.0 Percentage of Particpants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug); Doxorubicin (Drug); Vinblastine (Drug); Dacarbazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C |
65.1; 67.5; 73.0 | — |
| PRIMARY Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D |
0; 30 | — |
| SECONDARY Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C |
26.18; 16.59; 18.17 | — |
| SECONDARY Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C |
31.7; 13.8; 21 | — |
| SECONDARY Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C |
43.47; 30.32; 26.41 | — |
| SECONDARY Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C |
33.3; 57.5; 54.0 | — |
| SECONDARY Duration of PR Based on IRRC Assessments in Cohorts A, B, and C |
12.78; 10.58; 14.65 | — |
| SECONDARY Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C |
69.8; 73.8; 70.0 | — |
| SECONDARY Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C |
39.10; 25.26; 28.85 | — |
| SECONDARY Treatment Discontinuation Rate in Cohort D |
2; 5; 5; 6 | — |
| SECONDARY Number of Participants Who Died in Cohort D |
0; 1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) in Cohort D |
48; 49 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) in Cohort D |
2; 10 | — |
| SECONDARY Number of Participants With AEs Leading to Discontinuation in Cohort D |
1; 3 | — |
| SECONDARY Number of Participants With AEs Leading to Dose Delay in Cohort D |
3; 29 | — |
| SECONDARY Number of Participants With Select AEs in Cohort D |
6; 13; 2; 3; 0; 3 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase |
1; 1; 0; 0; 1; 5 | — |
| SECONDARY Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase |
12; 8; 3; 1; 8; 5 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase |
2; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase |
4; 1; 1; 0; 0; 0 | — |
| SECONDARY Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D |
66.7 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C - enrollment closed)
- Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrollment closed)
- Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)
Exclusion Criteria
- Known central nervous system lymphoma
- Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
- Prior allogeneic stem cell transplantation (SCT)
- Chest radiation ≤ 24 weeks prior to first dose
- Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
Data sourced from ClinicalTrials.gov (NCT02181738). 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.