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Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
NCT05308446 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- BIOLOGICAL Nivolumab
- DRUG Encorafenib
Study Locations (20)
California
- Mercy Cancer Center - Carmichael — Carmichael
- Mercy San Juan Medical Center — Carmichael
- Kaiser Permanente Dublin — Dublin
- Mercy Cancer Center - Elk Grove — Elk Grove
- Kaiser Permanente-Fremont — Fremont
- Kaiser Permanente-Fresno — Fresno
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
- Kaiser Permanente-Modesto — Modesto
- Kaiser Permanente-Oakland — Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- Mercy Cancer Center - Rocklin — Rocklin
- Kaiser Permanente-Roseville — Roseville
- Kaiser Permanente Downtown Commons — Sacramento
- Mercy Cancer Center - Sacramento — Sacramento
- Kaiser Permanente-South Sacramento — Sacramento
- Kaiser Permanente-San Francisco — San Francisco
- Kaiser Permanente-Santa Teresa-San Jose — San Jose
- Kaiser Permanente San Leandro — San Leandro
- Kaiser Permanente Medical Center - Santa Clara — Santa Clara
Arizona
- CTCA at Western Regional Medical Center — Goodyear
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05308446
The ClinicalTrials.gov registry entry for NCT05308446 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Stage III Rectal Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05308446 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05308446 about?
NCT05308446 is a clinical study titled "Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation". 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 (unresec...
What is the current status of trial NCT05308446?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2022-07-19. Estimated completion is 2026-02-28.
What conditions does trial NCT05308446 study?
This clinical trial studies the following conditions: Stage III Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Metastatic Rectal Adenocarcinoma, Metastatic Colon Adenocarcinoma, Stage IV Colon Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05308446?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Encorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05308446?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05308446 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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