N=~700
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Key eligibility criteria*:
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Recurrent, unresectable, or metastatic disease
- Measurable disease according to RECIST v1.1
- KRAS, NRAS, and BRAF WT
- ECOG PS 0 or 1
Primary outcomes:
- PFS by BICR
- OS
Secondary outcomes†:
- Objective response rate by BICR and INV
- PFS by INV
- DOR by BICR and INV
- PFS2
- DCR by BICR and INV
- AEs by severity
- QoL
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
Ab, antibody; AE, adverse event; BICR, blinded independent central review; BRAF, v-Raf murine sarcoma viral oncogene homolog B1; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FOLFIRI, 5-fluorouracil, leucovorin, and irinotecan; INV, investigator assessment; KRAS, Kirsten rat sarcoma viral oncogene homolog; NRAS, neuroblastoma RAS viral oncogene homolog; MET, mesenchymal epithelial transition; OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival after subsequent therapy; QoL, quality of life; R, randomized; RECIST, Response Criteria in Solid Tumors; SC, subcutaneous; WT, wild type.