Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plu
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 sig
| Condition(s) | Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 1\. Male or female participants age ≥18 years at the time of informed consent. 2. Capable of giving signed informed consent/assent. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 4\. Participants with histologically or cytologically confirmed colorectal adenocarcinoma. 5\. Presence of a BRAF V600E mutation confirmed as per standard of care according to international guidelines at any time prior to Screening. 6\. Microsatellite stable (MSS) or Mismatch-Repair proficient (pMMR) disease confirmation assessed by local PCR or immunohistochemistry (IHC). 7\. Participants with CRC who have one of these criteria: 1. Locally advanced colorectal cancer with ini |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) |
| Locations | Madrid, Spain |
| Start date | 2024-04-16 |
| NCT ID | NCT06207656 |
| Official listing | https://clinicaltrials.gov/study/NCT06207656 |