CheckMate 067: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 067
This is a Phase 3, randomized, double-blind study of nivolumab monotherapy or nivolumab combined with ipilimumab versus ipilimumab monotherapy in adult ( 18 years) subjects with previously untreated unresectable or
metastatic melanoma. Subjects must have stage III (unresectable) or stage IV melanoma, as per the American Joint Committee on Cancer (AJCC) staging system, and must not have received prior therapy for the treatment of
Draft v0.21
Nivolumab CA209067
BMS-936558 Clinical Protocol
unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant therapy is allowed in the setting of completely resectable disease. PD-L1 status will be obtained by immunohistochemical (IHC) staining of PD-L1 protein prior to randomization. Subjects will be randomized 1:1:1 and stratified by PD-L1 status (positive vs. negative/indeterminate), BRAF Status (BRAF mutation positive, BRAF wildtype), and AJCC M stage (M0/M1a/M1b vs. M1c). One cycle of treatment is defined as six weeks. Subjects will be treated with one of the following:
- Arm A: nivolumab 3 mg/kg IV every 2 weeks + ipilimumab-placebo every 3 weeks for the first 2 cycles
- Arm B: ipilimumab X mg/kg IV combined with nivolumab X mg/kg IV every 3 weeks for 4 doses then nivolumab 3 mg/kg IV Q2W + nivolumab-placebo on weeks 3 and 5 for cycles 1 and 2.
- Arm C: ipilimumab 3mg/kg IV every 3 weeks for a total of 4 doses + nivolumab-placebo on weeks 1, 3, 4 and 5 for cycles 1 and 2 then Q2W. For Arm B, the dose/schedule will be finalized in the protocol and rationale supported by CA209004 (A Phase 1b, Open-Label, Multicenter, Multidose, Dose-Escalation Study of MDX-1106 (BMS-936558)(Nivolumab) in Combination with Ipilimumab (BMS-734016) in Subjects with Unresectable Stage III or Stage IV Malignant Melanoma). One cycle of treatment will be defined as six weeks. Dose reductions will be not be allowed.
