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NCT05308446 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
A Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage III Colon Cancer AJCC V8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT05308446: Active Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage III Colon Cancer AJCC V8, sponsored by National Cancer Institute (NCI).
NCT05308446 is a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage III Colon Cancer AJCC V8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, below the 111-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05308446, a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage III Colon Cancer AJCC V8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Conducted in all eligible participants according to the intent-to-treat principle using the stratified log rank test when a total of 66 PFS events have been observed. Estimated using the Kaplan-Meier method and compared using the stratified log rank test.
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 |
What the registry record for NCT05308446 still lists
NCT05308446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 111-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (24% lower).
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.
NCT05308446 names 20 study sites across 2 states, led by California, Arizona.
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.
What interventions are being tested in trial NCT05308446?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT05308446?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Stage III Rectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05308446's enrollment target sits among peer trials
84 4th of 15 higher than 12 of 15 other Stage III Rectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Rectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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