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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 1,545-participant average among 381 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.
Primary Outcome
Disease control rate is defined as the proportion of subjects who have a complete response, partial response, or stable disease at the time of a second restaging scan. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease is defined as a decrease of less than 30% or an increase of less than 20%. Increases of 20% or greater
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 |
What the registry record for NCT06268015 still lists
NCT06268015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06268015's enrollment target sits among peer trials
16 357th of 381 higher than 22 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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