Table 2.
Ongoing studies on colorectal cancers.
| NCT identifier | Setting | Phase | Study interventions | Number of patients | Primary endpoint |
|---|---|---|---|---|---|
| Checkpoint inhibitors | |||||
| NCT03026140 | Early stage colon cancer | II | Nivolumab + ipilimumab versus nivolumab + ipilimumab + celecoxib | 60 | Safety |
| NCT02260440 | Chemorefractory mCRC | II | Pembrolizumab + azacitidine | 40 | ORR |
| NCT02997228 | MSI-H mCRC | III | mFOLFOX6 bevacizumab versus atezolizumab versus atezolizumab + mFOLFOX6 bevacizumab | 439 | PFS |
| NCT02870920 | Chemorefractory mCRC | II | BSC + durvalumab + tremelimumab versus BSC | 180 | OS |
| NCT02788279 | Chemorefractory mCRC | III | Atezolizumab versus cobimetinib + atezolizumab versus regorafenib | 360 | OS |
| NCT02991196 | mCRC | I | DS-8273a + nivolumab | 20 | DLTs; MTD; ORR; DCR; TTP; PFS; |
| NCT02713373 | Unresectable mCRC | I-II | Cetuximab + pembrolizumab | 42 | PFS; ORR; safety and tolerability |
| NCT02981524 | mCRC | II | CY/GVAX + pembrolizumab | 30 | ORR |
| NCT02754856 | mCRC with resectable CLM | I | Tremelimumab + MEDI4736 + FOLFOX bevacizumab | 35 | Feasibility |
| NCT02933944 | RAS mutmCRC | I | TG02 versus TG02+ pembrolizumab | 20 | Safety; irORR |
| NCT02860546 | MSS mCRC | II | TAS-102 + nivolumab | 35 | irORR |
| NCT02948348 | Locally advanced RC | I-II | Chemoradiotherapy with capecitabine → nivolumab → surgical therapy | 50 | PCR |
| NCT02437071 | mCRC |
II | Pembrolizumab+ radiotherapy versus pembrolizumab+ ablation | 48 | ORR |
| NCT02060188 (CheckMate 142) | mCRC | II | Nivolumab/nivolumab + ipilimumab/nivolumab + ipilimumab 1st line/nivolumab + ipilimumab + cobimetinib/nivolumab + BMS-986016/nivolumab + daratumumab | 260 | ORR |
| NCT02512172 | mCRC | I | Oral CC, 486 & MK-3475 versus romidepsin & MK-3475, versus oral CC, 486 & romidepsin & MK-3475 | 30 | Degree of change in TIL |
| NCT02227667 | mCRC | II | MEDI4736 | 48 | ORR |
| NCT02563002 (KEYNOTE 177) | MSI-H mCRC | III | Pembrolizumab versus investigator's choice of standard of care |
270 | PFS |
|
| |||||
| Vaccines | |||||
| NCT02448173 | Stage II | III | OncoVAX + surgery versus surgery | 550 | DFS |
| NCT01890213 | Stage III | I | AVX701 | 12 | AE |
| NCT02718430 | mCRC with CLM | I | VXM01 | 24 | Safety and tolerability |
| NCT01741038 | mCRC | II-III | AlloStim® + cryoablation versus AlloStim + physician's choice (PC) | 450 | OS |
| NCT02615574 | Refractory mCRC | II | áDC1 vaccine+ CKM | 44 | OS |
|
| |||||
| Cytokines | |||||
| NCT02415699 | Stage III |
II-III | DC-CIK + chemotherapy versus chemotherapy | 100 | DFS |
| NCT02280278 | Stage III | III | Adjuvant CT → CIKCC versus adjuvant CT | 550 | DFS |
| NCT01929499 | Stages II-III | II | Adjuvant CT + synchronous CIKCC versus adjuvant CT → CIKCC versus adjuvant CT | 210 | DFS |
| NCT02466906 | Stage III | II | RhGM-CSF versus placebo | 60 | DFS |
| Oncolytic virus | |||||
| NCT01274624 | KRAS | II | REOLYSIN® + FOLFIRI, bevacizumab | 32 | DLTs |
| NCT01622543 | mCRC | II | FOLFOX + bevacizumab + reolysin versus FOLFOX + bevacizumab | 109 | PFS |
| Adoptive cell therapy study | |||||
| NCT03008499 | mCRC | I-II | High-activity natural killer versus no special treatment | 18 | Relief degree of tumours evaluated by RECIST |
| NCT02577588 | mCRC | I | Reactivated T cells | 10 | DLTs |
|
| |||||
| Adjuvant therapy | |||||
| NCT01545141 | Resectable CRC |
I-II | Surgery versus chemokine modulatory regimen (a combination of IFN, celecoxib, and rintatolimod prior to surgery | 50 | Change in the number of tumour-infiltrating CD8+ cells |
|
| |||||
| Immune modulators therapy | |||||
| NCT02077868 (IMPALA) | mCRC | III | Maintenance versus MGN1703 | 540 | OS |
| NCT02413853 (PRIMIER) | mCRC | II | PRI-724 + mFOLFOX6/bevacizumab versus mFOLFOX6/bevacizumab | 100 | PFS |
GC, gastric cancer; GEJC, gastroesophageal junction cancer; EC: esophageal cancer; NA, not assessed; MTD, maximum tolerated dose; MAD, maximum administered dose; DTL, dose limiting toxicity; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; DFS, disease-free survival; NS, not specified; RP2D, recommended dose of phase II; AE, adverse events; DCR, disease control rate; BSC, best supportive care; DCR disease control rate.