CheckMate 037
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Phase 3N = 405NCT01721746
- Population
- Unresectable or metastatic melanoma that had progressed after ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor
- Design
- Open-label randomised (2:1) phase 3 trial of nivolumab 3 mg per kilogram every 2 weeks versus investigator-choice chemotherapy (dacarbazine 1,000 mg per square metre, or paclitaxel 175 mg per square metre with carboplatin AUC 6, every 3 weeks). Primary end points were objective response proportion and overall survival; the report is the first interim analysis, covering the objective response end point.
- Primary endpoint
- ORR, OS
- Arms
- Nivolumab (experimental, n = 272): Nivolumab 3 mg per kilogram intravenously every 2 weeks
- Investigator-choice chemotherapy (control, n = 133): Dacarbazine 1,000 mg per square metre, or paclitaxel 175 mg per square metre with carboplatin area under the curve 6, every 3 weeks
- People
- Weber JS, senior author Larkin J
Δ ORR+21.1 points
Show the numbers
| Endpoint | Analysis | Nivolumab | Investigator-choice chemotherapy | Effect |
|---|---|---|---|---|
| ORRFirst 120 nivolumab-treated patients with at least 24 weeks of follow-up and 47 chemotherapy patients (per protocol) | interimWeber 2015 | 31.7% (23.5–40.8%) | 10.6% (3.5–23.1%) | Confirmed objective responses: 38 patients with nivolumab and 5 with chemotherapy. |
| Endpoint | Analysis | Nivolumab | Investigator-choice chemotherapy | Effect |
|---|---|---|---|---|
| ORRFirst 120 nivolumab-treated patients with at least 24 weeks of follow-up and 47 chemotherapy patients (per protocol) | interimWeber 2015 | 31.7% (23.5–40.8%) | 10.6% (3.5–23.1%) | Confirmed objective responses: 38 patients with nivolumab and 5 with chemotherapy. |