OncoMatch/Clinical Trials/NCT06207656
Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer
Is NCT06207656 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies EBC for colorectal cancer.
Treatment: EBC — As a result of the little benefit obtained from standard treatments and the poor prognosis of these patients, the BRAF-V600E mutant MSS aCRC represents an unmet medical need requiring clinical research. The combination of encorafenib, cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial, which also revealed treatment safety and tolerability to be acceptable. Compared to the control group (cetuximab and irinotecan or cetuximab and FOLFIRI), the triplet therapy cohort showed higher median overall survival (9.3 vs. 5.9 months) and response rates (26.8% vs. 1.8%). Grade 3 adverse events occurred in 65.8% and 64.2% of patients for triple-therapy and control groups, respectively. Based on these results, the investigators speculated that the combination of encorafenib, cetuximab and binimetinib could be used as induction therapy to improve treatment outcomes in BRAF-V600E-mutated MSS aCRC locally advanced initially unresectable but potentially resectable; initially resectable or initially unresectable but potentially resectable oligometastatic disease; and in patients with stage II-IV who have relapsed after chemotherapy (neo and/or adjuvant) or surgery, if the shorter time after resection or from treatment end to relapse is longer than 6 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF V600E
Presence of a BRAF V600E mutation confirmed as per standard of care according to international guidelines at any time prior to Screening
Required: MMR proficient
Mismatch-Repair proficient (pMMR) disease confirmation assessed by local PCR or immunohistochemistry (IHC)
Required: MSI microsatellite stable
Microsatellite stable (MSS) ... disease confirmation assessed by local PCR or immunohistochemistry (IHC)
Required: KRAS wild-type
Known RAS-mutant colorectal adenocarcinoma [excluded]
Required: NRAS wild-type
Known RAS-mutant colorectal adenocarcinoma [excluded]
Required: HRAS wild-type
Known RAS-mutant colorectal adenocarcinoma [excluded]
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: selective BRAF inhibitor (encorafenib, dabrafenib, vemurafenib, XL281, BMS-908662)
Previous treatment with any selective BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) and/or any selective MEK inhibitor prior to screening
Cannot have received: selective MEK inhibitor
Previous treatment with any selective BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) and/or any selective MEK inhibitor prior to screening
Cannot have received: systemic anticancer therapy
Exception: Patients with resected (R0 or R1 resections) metastasis of CRC treated with or without adjuvant or neoadjuvant chemotherapy (+/- antiEGFR or bevacizumab) would be includible if the time from the resection or from the end of the adjuvant treatment (the later) to the relapse of CRC were longer than 6 months; Patients with previous adjuvant or neoadjuvant chemotherapy for resected St II/III CRC would be eligible if the time from the resection or from the end of the adjuvant treatment (the later) to the relapse of CRC were longer than 6 months
Previous systemic anticancer therapy for CRC, with the following exceptions: ... (see above for exceptions)
Cannot have received: systemic regimen in first line treatment for metastatic CRC
Prior systemic regimen in first line treatment for metastatic CRC in patients with unresectable or non-potentially resectable metastatic (M1) disease
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; Platelets ≥100 × 10^9/L; Hemoglobin ≥9.0 g/dL (with or without blood transfusions)
Kidney function
Estimated creatinine clearance ≥50 mL/min according to Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance, or according to local institutional standard method
Liver function
Serum total bilirubin ≤1.5 x ULN (exceptions for direct/indirect bilirubin and non-hepatic causes); ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases
Adequate bone marrow function ... Adequate hepatic and renal function ... see above for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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