Table 1. . Select randomized trials investigating immune checkpoint blockers in melanoma.
Author | Year | Phase | Setting | n | Treatments | ORR (%) | mOS (months) | Ref. |
---|---|---|---|---|---|---|---|---|
Anti-CTLA-4 agents | ||||||||
Hodi et al. | 2010 | III | Pretreated | 676 | Ipilimumab 3 mg/kg (A) vs ipilimumab 3 mg/kg + gp100 (B) vs gp100 (C) | 10.9 (A) vs 5.7 (B) vs 1.5 (C) | 10.1 (A) vs 10.0 (B) vs 6.4 (C) | [6] |
Robert et al. | 2010 | III | Treatment-naive | 502 | Ipilimumab 10 mg/kg + DTIC vs placebo + DTIC | 15.2 vs 10.3 | 11.2 vs 9.1 | [7] |
Ribas et al. | 2013 | III | Treatment-naive | 655 | Tremelimumab vs DTIC or TMZ | 10.7 vs 9.8 | 12.6 vs 10.7 | [28] |
Anti-PD-1 agents | ||||||||
Robert et al. | 2014 | I randomized | Pre-treated with anti-CTLA-4 | 173 | Pembrolizumab 2 vs 10 mg/kg | 26 vs 26 | NR | [29] |
Weber et al. | 2014 | III | Pre-treated with anti-CTLA-4 | 370 | Nivolumab 3 mg/kg vs CT | 32 vs 11 | NA | [30] |
Robert et al. | 2015 | III | Treatment-naive | 418 | Nivolumab 3 mg/kg vs DTIC | 40 vs 13.9 | NR vs 10.8 | [8] |
Robert et al. | 2015 | III | Up to one prior systemic treatment | 834 | Pembrolizumab 10 mg/kg every 2 weeks vs every 3 weeks vs ipilimumab 3 mg/kg | 33.7 vs 32.9 vs 11.9 | NR | [31] |
Anti-PD-1 in combination with anti-CTLA-4 | ||||||||
Postow et al. | 2015 | II randomized | Treatment-naive | 142 (109 BRAF wild-type) | Ipilimumab 3 mg/kg + nivolumab 1 mg/kg followed by nivolumab 3 mg/kg vs ipilimumab 3 mg/kg+ placebo | 61 vs 11† | NR | [32] |
†Among patients with BRAF wild-type tumors.
CT: Investigator's choice of chemotherapy; DTIC: Dacarbazine; mOS: Median overall survival; NA: Not available or not reported; NR: Not reached; ORR: Overall response rate (complete response + partial response); TMZ: Temozolomide.