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NCT06300463 · ClinicalTrials.gov registry record · Phase 2
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
A Phase 2 study of Colorectal Cancer and Liver Metastases, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06300463: Recruiting Phase 2 study of Colorectal Cancer and Liver Metastases, sponsored by Weill Medical College of Cornell University.
NCT06300463 is a Phase 2 study of Colorectal Cancer and Liver Metastases that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 24 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06300463, a Phase 2 study of Colorectal Cancer and Liver Metastases, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are: * whether these combinations of immunotherapy change the tumor microenvironment in the liver * whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases Participants will be randomly assigned to one of the following: * Botensilimab and balstilimab * Botensilimab, balstilimab, and AGEN1423 * Botensilimab, balstilimab, and radiation Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.
Primary Outcome
Preliminary immunological response to treatment will be assessed by comparison of the CD8:Treg ratios in tumor tissue obtained during standard of care surgical resection between treatment arms. CD8:Treg ratio will be assessed by flow cytometry
Conditions Studied
Interventions
- RADIATION Radiation
- DRUG Balstilimab
- DRUG Botensilimab
- DRUG AGEN1423
Study Locations (1)
New York
- Weill Cornell Medicine/NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What NCT06300463 shows while recruiting
NCT06300463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Radiation is the first listed.
NCT06300463 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06300463 about?
NCT06300463 is a clinical study titled "Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases". The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are: * whether th...
What is the current status of trial NCT06300463?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-03-26. Estimated completion is 2027-03.
What conditions does trial NCT06300463 study?
This clinical trial studies the following conditions: Colorectal Cancer, Liver Metastases, Colorectal Cancer Metastatic.
What interventions are being tested in trial NCT06300463?
The interventions under investigation include: Radiation (RADIATION), Balstilimab (DRUG), Botensilimab (DRUG), AGEN1423 (DRUG).
Who is sponsoring clinical trial NCT06300463?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06300463 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
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 NCT06300463's enrollment target sits among peer trials
24 333rd of 381 higher than 44 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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