Table 1.
Clinical trials on cytotoxic T lymphocyte antigen 4
| Target molecule | Drug name | Study phase | Study design | Status | Condition | Intervention | Cohort | Estimated enrollment | Dose | End point | Study Arm | Adverse event | Response | Survival | Ref. |
| CTLA-4 | Ipilimumab (BMS-734016/MDX-010) | 1 | NA | Active | PC | Palliative | Locally advanced | 28 | DE | Safety (MTD, DLT) | Ipilimumab, Gemcitabine | NA | NA | NA | NCT01473940 |
| Not recruiting | Metastatic | Efficacy (RR, PFS, OS) | |||||||||||||
| 2 | Randomized | Recruiting | PC | Palliative | Metastatic | 92 | 3 mg/kg | Safety (AE) | Ipilimumab, GVAX (Arm A) | NA | NA | NA | NCT01896869 | ||
| Efficacy (OS, PFS, ORR, DoR) | FOLFIRINOX (Arm B) | ||||||||||||||
| Tremelimumab (CP-675/CP-675,206) | 2 | NA | Recruiting | PC, BlC, BC | Palliative | Metastatic | 77 | NA | Safety | Tremelimumab (Arm A) | NA | NA | NA | NCT02527434 | |
| Efficacy (ORR, DoR, DCR, PFS, OS, BoR) | Durvalumab (Arm B) | ||||||||||||||
| Tremelimumab, Durvalumab (Arm C) | |||||||||||||||
| 2 | Randomized | Recruiting | PC | Palliative | Metastatic | 130 | NA | Safety | Durvalumab (Arm A) | NA | NA | NA | NCT02558894 | ||
| Efficacy (ORR, DoR, DCR, PFS) | Durvalimab, Tremelimumab (Arm B) | ||||||||||||||
| PK | |||||||||||||||
| Antidrug Antibody Presence | |||||||||||||||
| 1 | Randomized | Recruiting | PC, NSCLC, HNSCC | Palliative | Locally advanced | 108 | NA | Safety (AE, DLT) | Durvalumab, Mogamulizumab (Arm A) | NA | NA | NA | NCT02301130 | ||
| Metastatic | Tremelimumab, Mogamulizumab (Arm B) | ||||||||||||||
| 1 | Non-randomized | Recruiting | PC, NSCLC, BC, MM | Palliative | Metastatic | 30 | 1 mg/kg | Safety (AE) | Durvalumab, Tremelimumab, Radiotherapy | NA | NA | NA | NCT02639026 | ||
| Efficacy |
ORR: Overall response rate; DLT: Dose limiting toxicity; AE: Adverse event; MTD: Maximum tolerance dose; NA: Not available.