Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)
Trial Parameters
Brief Summary
COSENSE-1 is an unblinded, phase II, single-armed, single center feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens, for male and female participants aged 18 and older, with microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC), that is incurable or not resectable with curative intent.
Eligibility Criteria
Inclusion Criteria: General conditions: 1. Age 18 or older 2. ECOG performance status 0 or 1 3. Obtained informed consent 4. Acceptable organ function (defined in publicly available protocol) 5. Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol) Disease and treatment specific conditions: 6. Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum 7. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion) 8. Patient has metastatic or primary lesion available for biopsy 9. Patient has measurable or evaluable disease per RECIST (version 1.1) 10. The oxaliplatin-based regimen FOLFOX (+/- antibody) versus the irinotecan-based regimen FOLFIRI (+/- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy