Table 2.

Ongoing trials investigating retreatment with immune checkpoint inhibitors after disease progression in solid tumors.

Trial	Phase	Cancer type	Prior treatment	Retreatment regimen	Inclusion criteria	Sample size	Primary endpoint
UNISON (NCT03177239)	II	Non-clear cell renal cell carcinoma (nccRCC)	Nivolumab	Nivolumab plus ipilimumab	Progressive disease	36	ORR
SENSITIZE (NCT03278665)	Ⅰb/II	Melanoma	Anti-PD-1 treatment	Pembrolizumab plus domatinostat (a histone deacetylase inhibitor)	Primary resistance	40	Incidence of adverse events
PRIME002 (ACTRN12618000053224)	II	Melanoma	Anti-PD-1 treatment	Azacitidine plus carboplatin; followed by avelumab	Primary resistance	NR	ORR, SD, CBR
OPTIM (2017-003349-14)	II	Squamous carcinoma of the head and neck (SCCHN)	Nivolumab	Nivolumab plus ipilimumab versus chemotherapy	Progressive disease	157	ORR
ILLUMINATE 301 (NCT03445533)	III	Melanoma	Anti-PD-1 treatment	Ipilimumab plus IMO-2125 [a Toll-like receptor (TLR) 9 agonist] versus ipilimumab	Progressive disease during or after anti-PD-1 therapy	454	OS, ORR
Replay (NCT03526887)	II	Non-small cell lung cancer (NSCLC)	Anti-PD-(L)1 treatment	Pembrolizumab	Progressive disease	110	ORR
NCT03126331	II	Renal cell carcinoma (RCC)	Nivolumab or nivolumab plus ipilimumab	Nivolumab or nivolumab plus ipilimumab	Progressive disease	40	Proportion of patients able to receive intermittent therapy, ORR
NCT03085719	II	SCCHN	Anti-PD-1 treatment	Radiation plus pembrolizumab	Progressive disease	26	ORR
NCT04322643	II	Urothelial carcinoma	Pembrolizumab or atezolizumab or durvalumab or nivolumab avelumab	Same agent as previous treatment	Progressive disease	20	Number of participants that sustain a response post ICI suspension
NCT03697304	II	Advanced solid tumors	Anti-PD-(L)1 treatment	BI 754091 (an anti-PD-1 agent) plus BI 754111 [an anti-lymphocyte activation gene-3 (LAG-3) agent] versus BI 754091 plus BI 836880 [an anti-vascular endothelial growth factor (VEGF) agent]	Primary or secondary resistance	260	ORR
HUDSON (NCT03334617)	II	NSCLC	Anti-PD-(L)1 therapy	Durvalumab plus AZD9150 or AZD6738 or vistusertib or olapanib or oleclumab or trastuzumab deruxtecan or cediraniba	Progressive disease	320	ORR
NCT03737123	II	Urothelial carcinoma	Anti-PD-(L)1 treatment	Atezolizumab plus carboplatin and gemcitabine or docetaxel	Progressive disease	33	PFS
NCT04088500	II	RCC	Nivolumab plus ipilimumab; followed by nivolumab	Nivolumab plus ipilimumab	Progressive disease	100	DCR
NCT03003676	II	Melanoma	Anti-PD-1 treatment	ONCOS-102 (an oncolytic adenovirus) followed by pembrolizumab	Progressive disease	21	Incidence of adverse events
NCT03177239	II	NccRCC	Nivolumab	Nivolumab plus ipilimumab	Progressive disease	85	ORR
NCT03262779	II	NSCLC	Anti-PD-(L)1 treatment	Nivolumab plus ipilimumab	Progressive disease	50	ORR
NCT02743819	II	Melanoma	Anti-PD-(L)1 treatment	Pembrolizumab plus ipilimumab	Progressive disease or stable disease	70	ORR

^aVistusertib is a mammalian target of rapamycin (mTOR) inhibitor; olapanib is a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor; oleclumab is an anti-CD73 monoclonal antibody; trastuzumab deruxtecan is an antibody-drug conjugate; cediranib is a VEGF signaling inhibitor.

CBR, clinical benefit rate; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; SD, stable disease.