Immune checkpoint therapy for pancreatic cancer

Table 2 Clinical trials on programmed cell death 1

Target molecule	Drug name	Study phase	Study design	Status	Condition	Intervention	Cohort	Estimated enrollment	Dose	End point	Study Arm	Adverse event	Response	Survival	Ref.
PD-1	Nivolumab (BMS-936558/MDX-1106/ONO-4538)	1|2	Randomized	Recruiting	PC	Neoadjuvant	Resectable	50	3 mg/kg	Safety	Cy/GVAX ( Arm A)	NA	NA	NA	NCT02451982
						Adjuvant				Efficacy (IRAEs, OS, DFS)	Cy/GVAX, Nivolumab (Arm B)
										Median-[IL17A] in Vaccine-induced Lymphoid Aggregates
		1|2	Non-randomized	Recruiting	PC, NSCLC, RCC, CrC, EC, UC	Palliative	Metastatic	49	NA	Safety	Nivolumab, Temsirolimus (Arm A)	NA	NA	NA	NCT02423954
										Efficacy	Nivolumab, Irinotecan (Arm B)
										RD	Nivolumab, Irinotecan, capecitabine (Arm C)
		1	Non-randomized	Recruiting	PC, NSCLC, CrC, MM, HNSCC, GBM	Palliative	Locally advanced	270	3 mg/kg	Safety (AE)	Phase 1a:	NA	NA	NA	NCT02526017
										Efficacy (OS; mOS, oyOS, DOR, PFS, ORR; CR, PR)	FPA008 (Arm A)
										Tolerability	FPA008, Nivolumab (Arm B)
										RD	Phase 1b:
										PK	MTD/RD FPA008, Nivolumab
										Immunogenicity
										PDA biomarkers
		1	Non-randomized	Recruiting	PC, OC, BC, CrC, RCC, MM, PrC, NSCLC	Palliative	Locally advanced	300	3 mg/kg	Safety	DE AM0010 (Arm A)	NA	NA	NA	NCT02009449
							Metastatic			Tolerability	DE AM0010, Paclitaxel/Docetaxel, Carboplatin/Cisplatin (Arm B)
										PK	DE AM0010, FOLFOX, (Arm C)
											DE AM0010, gemcitabine/nab-paclitaxel (Arm D)
											DE AM0010, Capecitabine (Arm E)
											DE AM0010, Paclitaxel (Arm F)
											DE AM0010, Pazopanib (Arm G)
											DE AM0010, Pembrolizumab (Arm H)
											DE AM0010, Nivolumab (Arm I)
											DE AM0010, Gemcitabine/carboplatin (Arm J)
	Pembrolizumab (MK-3475/SCH 900475)	2	NA	Not recruiting	PC	Palliative	Locally advanced	54	200 mg	Safety (IRAEs)	Cy/GVAX, Pembrolizumab, SBRT	NA	NA	NA	NCT02648282
										Efficacy (DMFS, OS, LPFS)
		2	Randomized	Active	PC	Palliative	Locally advanced	76	NA	Safety (TEAE)	ACP-196 (Arm A)	NA	NA	NA	NCT02362048
				Not recruiting			Metastatic			Efficacy	ACP-196, Pembrolizumab (Arm B)
		1|2	Randomized	Recruiting	PC	Neoadjuvant	Resectable	56	200 mg	Safety (DLT)	Pembrolizumab, Capecitabine, Radiotherapy	NA	NA	NA	NCT02305186
							Borderline resectable			Efficacy (DFS, OS, RR)
										[TILs]
		1|2	Non-randomized	Recruiting	PC, SCLC, OC, BC, Sarcoma	Palliative	Metastatic	90	2 mg/kg	Safety (AE)	Pembrolizumab, Gemcitabine (Arm A)	NA	NA	NA	NCT02331251
										Efficacy (ORR, OS, PFS)	Pembrolizumab, Gemcitabine, Docetaxel (Arm B)
										RD	Pembrolizumab, Gemcitabine, Nab-paclitaxel (Arm C)
											Pembrolizumab, Gemcitabine, Vinorelbine (Arm D)
											Pembrolizumab, Irinotecan (Arm E)
											Pembrolizumab, Liposomal, Doxorubicin (Arm F)
		1	Non-randomized	Recruiting	PC	Palliative	Locally advanced	50	200 mg	Safety	Pembrolizumab, Defactinib, Gemcitabine	NA	NA	NA	NCT02546531
							Metastatic			Efficacy
		1	NA	Active	PC, RC, NSCLC, BlC, ASN, RCC, CC, HCC, BC, MM, HNSCC, Sarcoma	Palliative	Metastatic	12	NA	Safety	Pembrolizumab, p53MVA	NA	NA	NA	NCT02432963
				Not recruiting						Efficacy (Clinical Response)
										Tolerability
		2	Non-randomized	Suspended	PC, ChC, GeC, CrC, HCC	Palliative	Metastatic	290	2 mg/kg	Safety	Pebrolizumab, Young TIL, Aldesleukin, Cyclophosphamide, Fludarabine	NA	NA	NA	NCT01174121
										Efficacy
		1	NA	Recruiting	PC	Palliative	Locally advanced	9	2 mg/kg	Safety (DLT)	Pembrolizumab, Reolysin, Gemcitabine/Irinotecan/Leucovorin with 5-FU	NA	NA	NA	NCT02620423
							Metastatic			Efficacy (ORR, PFS, OS)
		1|2	NA	Recruiting	PC, ChC, GeC, CrC	Palliative	Locally advanced	128	DE	Safety	Pembrolizumab, mFOLFOX6, Celecoxib	NA	NA	NA	NCT02268825
							Metastatic			Efficacy (RR, PFS, OS)
		1	Non-randomized	Recruiting	PC, OC, BC, CrC, RCC, MM, PrC, NSCLC	Palliative	Locally advanced	300	3 mg/kg	Safety	DE AM0010 (Arm A)	NA	NA	NA	NCT02009449
							Metastatic			Tolerability	DE AM0010, Paclitaxel/Docetaxel, Carboplatin/Cisplatin (Arm B)
										PK	DE AM0010, FOLFOX, (Arm C)
											DE AM0010, gemcitabine/nab-paclitaxel (Arm D)
											DE AM0010, Capecitabine (Arm E)
											DE AM0010, Paclitaxel (Arm F)
											DE AM0010, Pazopanib (Arm G)
											DE AM0010, Pembrolizumab (Arm H)
											DE AM0010, Nivolumab (Arm I)
											DE AM0010, Gemcitabine/carboplatin (Arm J)
	Pidilizumab (CT-011)	2	NA	Suspended	PC	Adjuvant	Resectable	29	3 mg/kg	Safety	Pidilizumab, Gemcitabine	NA	NA	NA	NCT01313416
										Efficacy (Median DFS)
		1	Non-randomized	Withdrawn	PC, OC, BC, CC, Sarcoma	Palliative	NA	0	DE	Safety	Pidilizumab, p53 Vaccine	NA	NA	NA	NCT01386502
										Efficacy

AE: Adverse event; NA: Not available.