Table 3.
Study population | Phase | Drugs | Primary outcomes | ClinicalTrials.gov identifier |
---|---|---|---|---|
BRAF-mutated melanoma | ||||
Sequential checkpoint blockade | 3 | Dab + Tram → Nivo + Ipi vs Nivo + Ipi → Dab + Tram | Overall survival: 2 years | NCT02224781 |
CheckMate 064 | 2 | Nivo → Ipi vs Ipi → Nivo | Treatment-related Gr 3–5 AEs | NCT01783938 |
Neoadjuvant checkpoint blockade | 2 | Nivo + Ipi → Nivo vs Nivo alone | Pathologic response and pCR | NCT02519322 |
Brain metastases | ||||
ABC | 2 | Nivo + Ipi → Nivo vs Nivo alone | Intracranial response rate | NCT02374242 |
CheckMate 204 | 2 | Nivo + Ipi → Nivo | Clinical benefit rate | NCT02320058 |
Rare melanoma subtypes | ||||
Metastatic uveal melanoma | 2 | Nivo + Ipi → Nivo | Overall response rate | NCT01585194 |
KIT mutation | 2 | Sunitinib + Nivo | Objective response rate | NCT02400385 |
Correlative analyses | ||||
Pharmacodynamic biomarker analysis | 1 | Nivo + Ipi vs Nivo alone | Immunomodulatory effects | NCT01621490 |
Relationship between tumor mutation burden and neoantigen load | 2 | Nivo + Ipi vs Nivo alone | Response rate | NCT02553642 |
Abbreviations: Dab, dabrafenib; Tram, trametinib; Nivo, nivolumab; Ipi, ipilimumab; Gr, grade; AEs, adverse events; pCR, pathologic complete response; ABC, anti-PD-1 brain collaboration; PD-1, programmed death-1.