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. 2023 Feb 9;9:959289. doi: 10.3389/fmed.2022.959289

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%