NCT05710406

Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

Active, enrolled Phase 2, PHASE3 Last updated 26 January 2026

What this trial tests

Phase 2, PHASE3 trial testing Encorafenib in Colon Adenocarcinoma in 1 participant. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 August 2023

Primary endpoint
1 June 2034

1 June 2034

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	16 August 2023
Primary completion	1 June 2034
Estimated completion	1 June 2034
Sites	202 locations across United States

Drugs / interventions tested

• Encorafenib (encorafenib) — full drug profile →
• Cetuximab (cetuximab) — full drug profile →
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Patient Observation

Conditions studied

• Colon Adenocarcinoma — all drugs for Colon Adenocarcinoma →
• Microsatellite Stable Colon Carcinoma — all drugs for Microsatellite Stable Colon Carcinoma →
• Stage IIB Colon Cancer AJCC v8 — all drugs for Stage IIB Colon Cancer AJCC v8 →
• Stage IIC Colon Cancer AJCC v8 — all drugs for Stage IIC Colon Cancer AJCC v8 →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

18 and older, any sex, with Colon Adenocarcinoma or Microsatellite Stable Colon Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
   Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412
2. Colorectal Cancer: Genetic Underpinning and Molecular Therapeutics for Precision Medicine.
   Dosunmu GT, Shergill A. · · 2024 · cited 8× · PMID 38790167 · DOI 10.3390/genes15050538
3. Clinical utility and future perspectives of liquid biopsy in colorectal cancer.
   Patelli G, Lazzari L, Crisafulli G, Sartore-Bianchi A, et al · · 2025 · cited 7× · PMID 40275061 · DOI 10.1038/s43856-025-00852-4
4. CSCO guidelines for metastatic colorectal cancer: personalized medicine in clinical practice.
   Yang M, Xu Z, Mi M, Ding Y, et al · · 2023 · cited 6× · PMID 37700433 · DOI 10.20892/j.issn.2095-3941.2023.0211
5. Entering the Era of Multidimensional Prognostication for Personalized Risk Assessment in Stage III Colon Cancer.
   Rousseau B, Cercek A. · · 2025 · cited 1× · PMID 40215432 · DOI 10.1200/jco-25-00205
6. Genomic alterations associated with early-stage disease and early recurrence in patients with colorectal cancer.
   Pappas L, Quintanilha JCF, Huang RSP, Parikh AR. · · 2025 · cited 1× · PMID 39531357 · DOI 10.1093/oncolo/oyae269
7. Defining the Prognostic Significance of BRAF V600E in Early-Stage Colon Cancer: A Systematic Review and Meta-Analysis.
   Dankner M, Dubé LR, Sorin M, Stein AJB, et al · · 2025 · PMID 41294686 · DOI 10.3390/curroncol32110624
8. Patients with Colorectal Cancer and <i>BRAF<sup>V600E</sup></i>-Mutation in Argentina: A Real-World Study-The EMOGI-CRC01 Study.
   Catani G, Kim S, Waisberg F, Enrico D, et al · · 2025 · PMID 40149341 · DOI 10.3390/cancers17061007