Table 5.
Immune checkpoint inhibitors based on articles
| Target molecule | Drug | Study phase | Study design | Condition | Intervention | Cohort | Enrollment | Dose | End point | Study Arm | Adverse event | Response | Survival | Ref. |
| CTLA-4 | Ipilimumab | 2 | Non-randomized | PC | Palliative | Locally advanced | 27 | 3 mg/kg | Efficacy (ORR; CR, PR) | Ipilimumab | 11% Grade 3-4 irAEs (Colitis: 1, Encephalitis: 1, Hypophysitis: 1) | No RECIST-response | NA | Royal et al[23] |
| (BMS-734016/MDX-010) | Metastatic | SD: delayed progression, RECIST-progressive disease (n:1) | ||||||||||||
| 1 | Randomized | PC | Palliative | Locally advanced | 30 | 10 mg/kg | Safety (AE) | Ipilimumab (Arm A) | 73%, 80% irAEs (Arm A, B) | SD: growth < 20% growth cut-off, 7w (n:1) , 22w (n:1) (Arm A) regression 17w (n:1), stabilization 59w (n:1), 71w (n:1) (Arm B) | mOS (95%CI:) IPI vs IPI, GVAX: 3.6 (2.5-9.2), 5.7 (4.3-14.7); | Le et al[24] | ||
| Metastatic | Efficacy (OS, ORR) | Ipilimumab, GVAX (Arm B) | 20% Grade 3-4 irAEs (Colitis: 1, GBS: 1, Nephritis: 1) (Arm A), (Rash: 1, Colitis: 1, Pneumonitis: 1) (Arm B) | HR = 0.51, 95%CI: 0.23-1.08, P = 0.072. | ||||||||||
| irAEs (p: 0.037) | yOS (95%CI:) IPI vs IPI, GVAX: 7% (1%-45%), 27% (11%-62%) | |||||||||||||
| Tremelimumab (CP-675/CP-675,206) | 1 | Non-randomized | PC | Palliative | Metastatic | 34 | 15 mg/kg | Safety (AE, DLT, MTD) | Tremelimumab DE (C6, C10, C15), Gemcitabine | Grade 3-4 irAEs (Asthenia: 1, Nausea: 1, Diarrhea: 1, Anemi: 1, Pruritus: 1, Hypertransaminasemia: 1) (C 10), (Asthenia: 3, Nausea: 2, Diarrhea:1, Anemi: 1, Neutropenia: 2, Hypertransaminasemia: 1, Thrombocytopenia:2) (C 15) SAE:11 (Dehydration-diarrhea: 1, ACS: 1, PE: 1, Hyperbilirubinemia: 1, Hematemesis: 1) (C10) (AKI: 1, GIB: 1, Hyperbilirubinemia: 2) (C15) | PR: 8w (n:2) (10.5%: 2/19) | mOS (95%CI:) C6 (6 mg/kg Tremelimumab), C10 (10 mg/kg Tremelimumab), C15 (15 mg/kg Tremelimumab): 5.3 (1.2-14.6), 8.0 (2.3-16.9), 7.5 (6.0-9.5) | Aglietta et al[27] | |
| Efficacy (OS, OR, PFS) | SD: > 10w [n:7 (n:2 completed study)] | |||||||||||||
| PD-L1 | BMS-936559 | 1 | Non-randomized | PC, NSCLC, MM, CrC, OC, GeC, RRC, BC | Palliative | Locally advanced | 207 (14 PDA) | DE | Safety (AE, MTD, DLT) | BMS-936559 | NA | No objective PDA-response | NA | Brahmer et al[79] |
| Metastatic | Efficacy (ORR) | |||||||||||||
| PK |
PDA: Pancreatic ductal adenocarcinoma; MTD: Maximum tolerance dose; ORR: Overall response rate; DLT: Dose limiting toxicity; NA: Not available; CTLA-4: Cytotoxic T lymphocyte antigen 4; PD-L1: Programmed cell death ligand 1.