Table 1.

Neoadjuvant trials with checkpoint inhibition.

Trial	Design	Intervention	Pathologic complete response	Grade 3–4 adverse events
Trials comparing adjuvant and neoadjuvant checkpoint inhibition
NCT02437279 Blank et al. 25	Phase Ib (n = 20)	Arm A: Adjuvant ipi + nivo for 4 cycles Arm B: Neoadjuvant ipi + nivo for 2 cycles before surgery, and 2 after surgery	Arm A: N/A Arm B: 30%	Arm A: 90% Arm B: 90%
Trials with only neoadjuvant arms
NCT02519322 Amaria et al. 26	Phase II (n = 23)	Arm A: Neoadjuvant nivo up to 4 cycles, adjuvant nivo up to 13 cycles Arm B: Neoadjuvant ipi + nivo up to 3 cycles, adjuvant nivo up to 13 cycles	Arm A: 25% Arm B: 45%	Arm A: 8% Arm B: 73%
NCT02434354 Huang et al. 47	Phase I (n = 29)	200 mg of pembrolizumab, single cycle 3 weeks prior to surgery then pembrolizumab q3w for a year following surgery	18.5%	-
NCT02977052 Rozeman et al.48,49	Phase II (n = 86)	Arm A: Neoadjuvant ipi (3mg/kg) + nivo (1 mg/kg) for 2 cycles Arm B: Neoadjuvant ipi (1 mg/kg) + nivo (3 mg/kg) for 2 cycles Arm C: Neoadjuvant ipi (3 mg/kg) for 2 cycles followed by neoadjuvant nivo (3 mg/kg) for 2 cycles	Arm A: 47% Arm B: 57% Arm C: 23%	Arm A: 40% Arm B: 20% Arm C: 50%
NCT02977052 Blank et al. 36	Phase II (n = 99)	Neoadjuvant ipi + nivo for 6 weeks, target node resection, if pCR, no lymphadenectomy, if pPR, lymphadenectomy only, if no response, lymphadenectomy + adjuvant nivo for 52 weeks	61% MPR	24%

Ipi, ipilimumab; MPR, major pathologic response, defined as  < 10% viable tumor cells; nivo, nivolumab; pCR, pathologic complete response.