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NCT05627635 · ClinicalTrials.gov registry record · Phase 1
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer
A Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05627635: Active Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by City of Hope Medical Center.
NCT05627635 is a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 20 participants, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05627635, a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the safety, side effects, best dose, and efficacy of FOLFOX and bevacizumab in combination with botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as FOLFOX, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Balstilimab and botensilimab are in a class of medications called monoclonal antibodies. They bind to proteins, called PD-L1 and CTLA-4, which is found on some types of tumor cells. These PD-1 and CTLA-4 proteins are known to affect the body's defense mechanism to identify and fight against tumor cells. The combination of these drugs may lead to improved disease control and outcomes in patients with MSS metastatic colorectal cancer.
Primary Outcome
Toxicity, graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. A dose limiting toxicity is a toxicity that occurs in the first 6 weeks of treatment with 3B-FOLFOX and that is attributed at least as possibly related to the study drugs
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Botensilimab
- BIOLOGICAL Bevacizumab
- BIOLOGICAL Balstilimab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2026-06-23 |
| Phase | Phase 1 |
What the registry record for NCT05627635 still lists
NCT05627635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (81% lower).
The record links to 7 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05627635 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05627635 about?
NCT05627635 is a clinical study titled "FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer". This phase I/II trial tests the safety, side effects, best dose, and efficacy of FOLFOX and bevacizumab in combination with botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spread from where it first started (primary site) to o...
What is the current status of trial NCT05627635?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-05-03. Estimated completion is 2026-06-23.
What conditions does trial NCT05627635 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma, Metastatic Colon Adenocarcinoma.
What interventions are being tested in trial NCT05627635?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Botensilimab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), Balstilimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05627635?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627635 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal 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 NCT05627635's enrollment target sits among peer trials
20 19th of 22 higher than 4 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal 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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