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NCT06268015 · ClinicalTrials.gov registry record · Phase 2
Botensilimab and Balstilimab Optimization in Colorectal Cancer
A Phase 2 study of Colorectal Cancer, sponsored by Nicholas DeVito, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06268015: Active Phase 2 study of Colorectal Cancer, sponsored by Nicholas DeVito, MD.
NCT06268015 is a Phase 2 study of Colorectal Cancer that is active but no longer recruiting, run by Nicholas DeVito, MD. The registered enrollment target is 16 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06268015, a Phase 2 study of Colorectal Cancer, is active but no longer recruiting, sponsored by Nicholas DeVito, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Balstilimab
- DRUG Botensilimab
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06268015
The ClinicalTrials.gov registry entry for NCT06268015 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Nicholas DeVito, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT06268015 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06268015 about?
NCT06268015 is a clinical study titled "Botensilimab and Balstilimab Optimization in Colorectal Cancer". This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and beva...
What is the current status of trial NCT06268015?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2024-11-18. Estimated completion is 2028-07.
What conditions does trial NCT06268015 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT06268015?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT06268015?
This trial is sponsored by Nicholas DeVito, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06268015 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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