Table 2. . Ongoing trials of neoadjuvant immunotherapy and targeted therapy in potentially resectable melanoma.
Study/NCT ID | Design | Randomized? | Primary outcome | Treatment used | Main findings/status |
---|---|---|---|---|---|
NCT02306850 | Phase IIB | N/A | Resectability rate at 24 weeks | Pembrolizumab | Recruiting |
NCT01608594 | Phase II | Yes | Safety | 10 mg/kg ipilimumab + HDI-α-2b or 3 mg/kg ipilimumab + HDI-α-2b | Recruiting |
NCT02339324 | Phase II | N/A | Safety | Pembrolizumab ± HDI-α-2b | Recruiting |
NCT02519322 | Phase II | Yes | Pathologic response | Neoadjuvant/adjuvant nivolumab vs neoadjuvant ipilimumab and nivolumab and adjuvant nivolumab | Not yet open |
Targeted therapy | |||||
NCT02303951 | Phase II | N/A | Percentage of patients who become resectable at 18 weeks | Vemurafenib and cobimetinib | Recruiting |
NCT02036086 | Phase II | N/A | Feasibility | Vemurafenib and cobimetinib | Recruiting |
NCT01972347 | Phase II | N/A | Proportion of viable tissue after 12 weeks of treatment | Dabrafenib + trametinib | Recruiting |
NCT02231775 | Phase II | Yes | 1-year recurrence-free survival | Surgery vs dabrafenib + trametinib followed by surgery | Recruiting |
T-VEC | |||||
NCT02211131 | Phase II | Yes | Recurrence-free survival | Surgery vs T-VEC followed by surgery | Recruiting |
HDI: High-dose IFN-α-2b; T-VEC: Talimogene laherparepvec.