CheckMate 039
Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies (Hodgkin lymphoma cohort)
Phase 1N = 23NCT01592370
- Population
- Heavily treated relapsed or refractory Hodgkin lymphoma; 78% enrolled after relapse following autologous stem-cell transplantation and 78% after relapse following brentuximab vedotin.
- Design
- Ongoing study report of the Hodgkin lymphoma cohort-expansion group of a phase 1 study (registry phase 1/2, multi-cohort haematology study): nivolumab 3 mg per kilogram every 2 weeks until complete response, tumour progression or excessive toxic effects. Objectives: safety, efficacy, and assessment of PDL1 and PDL2 loci and PD-L1 and PD-L2 protein expression. The registry record covers several cohorts and is titled for a multiple myeloma combination, so the Hodgkin cohort is identified from the publication.
- Arms
- Nivolumab (experimental, n = 23): Nivolumab 3 mg per kilogram every 2 weeks until complete response, progression or excessive toxic effects
- People
- Ansell SM
Show the numbers
| Endpoint | Analysis | Nivolumab | Control | Effect |
|---|---|---|---|---|
| ORRAll 23 treated patients | interimAnsell 2015 | 87% | — | 20 of 23 patients responded: 17% complete response and 70% partial response; the other 3 patients (13%) had stable disease. The abstract also reports a 24-week progression-free survival rate of 86%. Drug-related adverse events of any grade occurred in 78% and grade 3 events in 22% of patients. Single-arm, ongoing study. |
| Endpoint | Analysis | Nivolumab | Control | Effect |
|---|---|---|---|---|
| ORRAll 23 treated patients | interimAnsell 2015 | 87% | — | 20 of 23 patients responded: 17% complete response and 70% partial response; the other 3 patients (13%) had stable disease. The abstract also reports a 24-week progression-free survival rate of 86%. Drug-related adverse events of any grade occurred in 78% and grade 3 events in 22% of patients. Single-arm, ongoing study. |