N=~1000
contact details, please visit
the J&J Clinical Trial Finder
Key eligibility criteria*:
- Histologically or cytologically confirmed adenocarcinoma of left-sided colorectal cancer
- Unresectable or metastatic disease
- Measurable disease according to RECIST v1.1
- KRAS, NRAS, and BRAF WT
- ECOG PS 0 or 1
- Not received any prior systemic therapy for unresectable or metastatic colorectal cancer
Primary outcome:
- PFS by BICR
Secondary outcomes†:
- OS
- ORR by BICR and INV
- PFS by INV
- DOR by BICR and INV
- TTR by BICR and INV
- PFS2
- DCR by BICR and INV
- AEs by severity
- HRQoL
*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; HRQoL, health-related quality of life; INV, investigator assessment; KRAS,
Kirsten rat sarcoma viral oncogene homolog; MET, mesenchymal epithelial transition; mFOLFOX6, 5-fluorouracil,
leucovorin, and oxaliplatin; NRAS, neuroblastoma RAS viral oncogene homolog; ORR, objective response rate;
OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival after subsequent therapy; R,
randomized; RECIST v1.1, Response Criteria in Solid Tumors version 1.1; SC, subcutaneous; TTR, time to response; WT,
wild type.