. 2017 Sep 11;24(3):1073274817729243. doi: 10.1177/1073274817729243

Table 4.

Selected Trials for Immunotherapy.

Drug	Common Toxicities	Best Response
Nivolumab (dose expansion 3 mg/kg)	Fatigue, pruritus, grades 3-4 increased AST/ALT	Preliminary phase 1/2 trial data of 47 patients showed 5% CR, 18% PR, 72% OS at 6 months⁶²
Nivolumab (dose expansion 3 mg/kg)	Fatigue, pruritus, grades 3-4 increased AST/ALT	Follow-up study with 206 noted PD of 55% and OS 6 months survival of 69%⁶⁴
Nivolumab (0.1-10 mg/kg for up to 2 years)	Rash, grades 3-4 increased AST/ALT	Initial phase 1/2 study showed 15% CR, 8% PR, 50% SD, 31% PD, median OS 15.1 months⁶²
Pembrolizumab (200 mg IV every 3 weeks up to 35 cycles or PD)	Pending study results	Phase 2 study ongoing, pending final results
		Primary end point is ORR
		Secondary end point is OS, safety/tolerability, PFS, CR, PD
Codrituzumab (1600 mg every 2 weeks after 2 loading doses)	Anemia, increased AST	Phase 2 study showed PFS of codrituzumab versus placebo to be 2.6 versus 1.5 months, respectively. OS is 8.7 versus 10 months⁷⁰
Pembrolizumab (200 mg IV every 3 weeks) + BSC versus placebo + BSC up to 35 cycles or until disease progression	Pending study results	Phase 3 study ongoing, pending final results
		Primary objective is PFS and OS
		Secondary objective is ORR, CR, PD
Pexa-Vec (10e9 PFU injections every 2 weeks × 3) + sorafenib (400 mg BID starting at week 6) versus sorafenib (400 mg BID from day 1)	Pending study results	Phase 3 study ongoing, pending final results
		Primary end point is OS
		Secondary end point is PFS, ORR, CR
		Safety, biomarkers, and quality of life will be evaluated

Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; BID, twice daily; BSC, best supportive care; CR, complete response; IV, intravenously; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PFU, plaque forming units; PR, partial response.