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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Colon Adenocarcinoma, Microsatellite Stable Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8

In brief

This phase II/III trial compares the effect of the combination of 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 is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. 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 combination after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Key facts

Study ID

NCT05710406

Run by

Alliance for Clinical Trials in Oncology

People needed

1

Starts

2023-08-16

Expected to finish

2034-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA:
• Pre-registration for central tumor testing will occur after colon resection. Pre-registration can occur at any time after surgery through a twelve week period after completion of standard adjuvant therapy
• BRAF V600 mutational status may be determined either locally or by central testing. This testing is mandatory prior to registration to determine eligibility. Tissue submission should be initiated as soon after surgery as possible. For tumors evaluated at local laboratories, formalin-fixed paraffin-embedded (FFPE) tumor tissue must still be submitted for central confirmation of BRAF status
• REGISTRATION (STEP 1) ELIGIBILITY CRITERIA:
• Histologically-proven stage III (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C) or high-risk (pT4) stage II colon adenocarcinoma. Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve) and must have been completely resected
• BRAF V600E mutation
• MMR proficient (pMMR) or microsatellite stable (MSS) tumor
• Histologic documentation: adenocarcinoma
• Stage: III (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C) or high-risk II (pT4)
• Tumor site: colon
• Patients must have received at least 3 months of adjuvant chemotherapy with either leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) (minimum of 5 cycles) or capecitabine and oxaliplatin (CAPOX) (minimum of 3 cycles)
• Adjuvant therapy must be completed at most 8 weeks prior to registration
• No other prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy) or radiation therapy for the current colon cancer is permitted
• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
• Absolute neutrophil count (ANC) >= 1.0 x 10\^9/L
• Platelet count >= 75 x 10\^9/L
• Hemoglobin > 9.0 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN
• Corrected QT (QTc) Interval =< 480 msec
• Creatinine = calculated (calc.) creatinine clearance >= 40 mL/min
• No evidence of active and uncontrolled bacterial or viral infection (including active hepatitis B or hepatitis C infection) within 2 weeks prior to start of study intervention; exceptions include:
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Where it is running

• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Emory Johns Creek Hospital — Johns Creek, Georgia, United States
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
• Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• The Queen's Medical Center - West Oahu — ‘Ewa Beach, Hawaii, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
• Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
• Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States
• Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
• Beebe South Coastal Health Campus — Millville, Delaware, United States

Full record on ClinicalTrials.gov

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