Table 1 Characteristics of studies included to determine which AEs to include in the PRO-CTCAE for melanoma patients
Trial | Design | Enrollment size N= | Study drug | Dose (mg/kg) |
|---|---|---|---|---|
Eggermont et al. [3] | Adjuvant, Randomized phase 3 | 951 | Ipilimumab | 10 |
Hodi et al. [2] | Phase 3 Randomized | 676 | Ipilimumab | 3 |
Larkin et al. [4] | Phase 3 randomized | 945 | Nivolumab Nivolumab/Ipilimumab Ipilimumab | 3; 1 + 3; 3 |
Postow et al. [17] | Double-blind Phase 2 – dose ranging | 142 | Ipilimumab or Ipilimumab/Nivolumab | 3; 3 + 1 |
Ribas et al. [19] | Phase 1b | 655 | Pembrolizumab Pembrolizumab | 10; 2 |
Ribas et al. [5] | Phase 2 | 540 | Pembrolizumab Pembrolizumab | 2; 10 |
Robert et al. [20] | Randomized, phase 2 | 418 | Nivolumab | 3 |
Robert et al. [18] | Phase 3 | 834 | Pembrolizumab ipilimunab | 10; 3 |
Weber et al. [21] | Randomized, open-label phase 3 | 405 | Nivolumab | 3 |
Weber et al. [22] | Randomized, open label, phase 2 | 140 | Nivolumab Ipilimumab | 3; 3 |