Table 10.
Approach | Combination | Phase | Primary Outcome | Status | ID |
---|---|---|---|---|---|
CV-301 | Capecitabine, Durvalumab | I/II | RP2D, PFS (8.5 months) | Not recruiting | NCT03376659 |
GVAX | Nivolumab, Cyclophosphamide | II | CD8+ count in TME | Recruiting | NCT03161379 |
GVAX | Nivolumab, Iplimumab, Cyclophosphamide, CRS-207 | II | ORR (4 years) | Recruiting | NCT03190265 |
GVAX | Nivolumab, Urelumab | II | IL17A expression | Recruiting | NCT02451982 |
GVAX | Pembrolizumab, Cyclophosphamide, Radiotherapy | II | DMFS (4 years) | Recruiting | NCT02648282 |
GVAX | BMS-813160 (CCR2/CCR5 antagonist), Nivolumab, multiple chemotherapy (Gemcitabine, Nab-Paclitaxel, 5-FU, Leucovorin, Irinotecan) | Ib/II | AE, SAE, ORR (2 years), DOR, PFS (24 weeks), decrease in Treg and TAMs | Recruiting | NCT03184870 |
GVAX | BMS-813160 (CCR2/CCR5 antagonist), Nivolumab, radiotherapy | I/II | DLT, CD8+ and CD37+ in TME | Recruiting | NCT03767582 |
CRS-207 | Epacadostat, Pembrolizumab, GVAX, Cyclophosphamide | II | RP2D, OS (6 month) | Recruiting | NCT03006302 |
CRS-207 | Nivolumab, Iplimumab, Cyclophosphamide, GVAX | II | ORR (4 years) | Recruiting | NCT03190265 |
Anti CEA CAR-T | - | I/II | AE | Recruiting | NCT04348643 |
Anti CEA CAR-T | Gemcitabine, Nab-Paclitaxel, NLIR + FU/FA | II | OS (12 months) | Not yet recruiting | NCT04037241 |
Anti Claudin18.2 CAR-T | - | Ib/II | AE, MTD, DLT, ORR (24 weeks) | Recruiting | NCT04581473 |
RP2D, recommended phase II dose; PFS, progression free survival; TME, tumour microenvironment; ORR, objective response rate; DMFS, distant metastasis free survival; AE, adverse events SAE, serious adverse events; DOR, duration of response; Treg, regulatory T cells; TAMs, tumour-associated macrophages; DLT, dose limiting toxicity; OS, overall survival; MTD, maximum tolerated dose.