Table 1.
Ongoing neoadjuvant trials with checkpoint inhibition in melanoma.
Trial | Design | N' of patients | Intervention | Pathologic complete response |
---|---|---|---|---|
Trials comparing adjuvant and neoadjuvant checkpoint inhibition | ||||
NCT02437279 (OpACIN) |
Phase Ib | 20 | Arm A: Adjuvant ipi + nivo for 4 cycles | Arm A: N/A |
Arm B: Neoadjuvant ipi + nivo for 2 Cycles before surgery, and 2 after surgery | Arm B: 30% | |||
Trials with only neoandjuvant arms | ||||
NCT02519322 | Phase II | 23 | Arm A: Neoadjuvant nivo up to 4 cycles, adjuvant nivo up to 13 cycles | Arm A: 25% |
Arm B: Neoadjuvant ipi + nivo up to 3 cycles, adjuvant nivo up to 13 cycles | Arm B: 45% | |||
NCT02434354 | Phase I | 29 | 200 mg of pembrolizumab, single cycle 3 weeks prior to | 18,50% |
surgery then pembrolizumab q3w for a year following surgery | ||||
NCT02977052 (OpACIN-neo) | Phase II | 86 | Arm A: Neoadjuvant ipi (3 mg/kg) + nivo (1 mg/kg) for 2 cycles | Arm A: 47% |
Arm B: Neoadjuvant ipi (1 mg/kg) + nivo (3 mg/kg) for 2 cycles | Arm B: 57% | |||
Arm C: Neoadjuvant ipi (3 mg/kg) for 2 cycles followed by neoadjuvant nivo (3 mg/kg) for 2 cycles | Arm C: 23% | |||
NCT02977052 | Phase II | 99 | Neoadjuvant ipi + nivo for 6 weeks, target node resection, if pCR, no lymphadenectomy, | 61% MPR |
if pPR, lymphadenectomy only, if no response, lymphadenectomy + adjuvant nivo for 52 weeks | ||||
Ipi, ipilimumab; MPR, major pathologic response, defined as < 10% viable tumor cells; nivo, nivolumab; pCR, pathologic complete response. | ||||
NCT02231775 | Phase II | 21 | Arm A: Upfront surgery with consideration of adjuvant therapy | Arm A: NA |
Arm B: Neoadjuvant dabrafenib and trametinib for 8 weeks followed by adjuvant dabrafenib and trametinib for 44 weeks | Arm B: 50% | |||
NCT01972347 (Neo Combi) | Phase II | 35 | Neoadjuvant dabrafenib and trametinib for 12 weeks, adjuvant therapy for 40 weeks | 49% |
Trials with only neoadjuvant arms | ||||
NTR4654 | Phase II | 20 | Neoadjuvant dabrafenib and trametinib for 8 weeks in patients with unresectable disease followed by surgery if resectable | 28.6% |