Trials combining agents targeting DNA repair and ICB
Study identifier | Agents | Class of drugs | Design | Patients/estimated accrual | Primary endpoint |
---|---|---|---|---|---|
NCT02657889 | Niraparib plus pembrolizumab | PARP inhibitor plus anti–PD-1 antibody | Phase I/II | Recurrent triple negative breast cancer (TNBC) or ovarian cancer (OC) | RP2D (Phase I) |
N = 114 | ORR (Phase II) | ||||
NCT02660034 | BGB-290 plus BGB-A317 | PARP inhibitor plus anti–PD-1 antibody | Phase IA/IB | Advanced solid tumors | RP2D (Phase I) |
N = 124 | ORR (Phase II) | ||||
NCT02849496 | Veliparib plus atezolizumab | PARP inhibitor plus anti–PD-L1 antibody | Phase II, Open Label, Randomized | Unresectable stage III or IV BRCA1/2-mutated TNBC | PFS |
N = 90 | |||||
NCT02734004 | Olaparib plus durvalumab | PARP inhibitor plus anti–PD-L1 antibody | Phase I/II | Advanced/recurrent solid tumors | Safety and disease control rate |
N = 133 | |||||
NCT02484404 | Olaparib plus durvalumab plus cediranib | PARP inhibitor plus anti–PD-L1 antibody plus VEGFR1,2,3 inhibitor | Phase I/II | Advanced/recurrent solid tumors | RP2D (Phase I) |
N = 338 | ORR or PFS (Phase II) | ||||
NCT02571725 | Olaparib plus tremelimumab | PARP inhibitor plus anti–CTLA-4 antibody | Phase I/II | Recurrent BRCA1/2-mutated OC | RP2D (Phase I) |
N = 50 | ORR (Phase II) | ||||
NCT02953457 | Olaparib plus durvalumab plus tremelimumab | PARP inhibitor plus anti–PD-L1 antibody plus anti–CTLA-4 antibody | Phase I/II | Recurrent BRCA1/2-mutated OC | MTD (Phase I) |
N = 39 | PFS (Phase II) | ||||
NCT02264678 | AZD6738 plus durvalumab | ATR inhibitor plus anti–PD-L1 antibody | Phase I | Advanced head and neck squamous cell carcinoma or non–small cell lung cancer | RP2D |
N = 114 (all arms, including other combinations) |
Abbreviations: R2PD, recommended phase II dose; ORR, overall response rate;
MTD, maximum tolerated dose;
PFS, progression-free survival.