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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05571293
The ClinicalTrials.gov registry entry for NCT05571293 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Balstilimab is the first listed.
NCT05571293 reports 0 study locations.
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.
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