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NCT05571293 · ClinicalTrials.gov registry record · Phase 2
Combination Immunotherapy in Colorectal Cancer
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT05571293: Active Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT05571293 is a Phase 2 study that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05571293, a Phase 2 study, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.
Primary Outcome
Resected tumors will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H\&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response), corresponding to Mandard tumor reg
Interventions
- DRUG Balstilimab
- DRUG Botensilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What the registry record for NCT05571293 still lists
NCT05571293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Balstilimab is the first listed.
NCT05571293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05571293 about?
NCT05571293 is a clinical study titled "Combination Immunotherapy in Colorectal Cancer". This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they ...
What is the current status of trial NCT05571293?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-03-17. Estimated completion is 2026-07.
What interventions are being tested in trial NCT05571293?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT05571293?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05571293's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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