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NCT05308446ACTIVE_NOT_RECRUITINGanonymous

Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

Sponsor

Source record

National Cancer Institute (NCI)

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Cetuximab, Encorafenib, Nivolumab

Indication / condition

AI-normalized

Metastatic Colon Adenocarcinoma

Intervention

Source record

Cetuximab, Encorafenib, Nivolumab

Source & freshness

Source record

NCT ID

NCT05308446

Original source

ClinicalTrials.gov

Source last updated

Jun 03, 2026

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05308446

Title

Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

Sponsor

National Cancer Institute (NCI)

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE2

Condition raw

Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma

Condition normalized

Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Cetuximab, Encorafenib, Nivolumab

Target normalized

Cetuximab, Encorafenib, Nivolumab

Interventions

Cetuximab, Encorafenib, Nivolumab

Public preview

Source record

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. 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 cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

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