Table 1.
Main ongoing studies (clinicaltrial.gov) for metastatic colorectal cancer
|
Study
|
Treatment
|
Phase of study
|
Primary objectives
|
| COLOMATE trial | |||
| NCT03765736 | Specific targeted treatment arms based on the molecular profiles | Phase II prospective trial | (1) To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies; and (2) To facilitate clinically annotated genomic analyses |
| CALGB (Alliance)/SWOG 80405 | |||
| NCT00265850 | Bevacizumab or cetuximab combined with the same chemotherapy | Phase III, randomized, open-label, multicentre study | To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumours |
| KRYSTAL 10 | |||
| NCT04793958 | MRTX849 (inhibitor of KRAS G12C) in Combination with Cetuximab vs Chemotherapy | Phase III, open-label, randomized | Comparing the efficacy of MRTX849 administered in combination with cetuximab vs chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation |
| C-PRECISE-01 | |||
| NCT04495621 | MEN1611 + Cetuximab | Phase Ib/II, open-label, multicentre study | MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens |
| NCT04096417 | Pemigatinib | phase II, multicentre, single-Arm study | To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable CRC harbouring activating FGFR alterations |
| MOUNTAINEER | |||
| NCT03043313 | Trastuzumab+tucatinib | Phase II open label study | Tucatinib combined with trastuzumab in patients with HER2+ metastatic colorectal cancer |
| NAVIGATE | |||
| NCT02576431 | Larotrectinib | Phase II open label study | Investigate the efficacy of larotrectinib for the treatment of advanced solid tumours harbouring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1–3 in children and adults |
| NCT03829410 | Onvansertib (PCM-075) | Phase Ib/II open label study | Determine the safety and efficacy of Onvansertib in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation |
| STARTRK-2 | |||
| NCT02568267 | Entrectinib (RXDX-101) | Phase 2 basket study | Treatment of patients with Locally Advanced or metastatic solid tumours that harbour NTRK1/2/3, ROS1, or ALK gene rearrangements |
| NCT03724851 | Vactosertib (TGF-β receptor I kinase inhibitor) + pembrolizumab | Phase 2, open label study | Safety, tolerability, pharmacokinetics and antitumour activity of vactosertib in combination with pembrolizumab in patients with mCRC including CMS4 or diffuse GC/GEJC |
EGFR: Epidermal growth factor receptor; TGF-β: Transforming growth factor-β.