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NCT04963283 · ClinicalTrials.gov registry record · Phase 2
Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer
A Phase 2 study of Colorectal Cancer and Colon Cancer, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 5
- Study locations
NCT04963283: Active Phase 2 study of Colorectal Cancer and Colon Cancer, sponsored by University of Colorado, Denver.
NCT04963283 is a Phase 2 study of Colorectal Cancer and Colon Cancer that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 48 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04963283, a Phase 2 study of Colorectal Cancer and Colon Cancer, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 5
- Study locations
Study Summary
Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cabozantinib and nivolumab in patients with metastatic MSS CRC in the third line setting and beyond.
Primary Outcome
DCR is defined using the RECIST 1.1 criteria as the proportion of subjects who have achieved confirmed complete response (CR), confirmed partial response (PR) or stable disease (SD) at 16-weeks.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Cabozantinib
Study Locations (5)
Colorado
- University of Colorado Hospital - Aurora
- UCHealth Memorial Hospital Central - Colorado Springs
- UCHealth Harmony Campus - Fort Collins
- UCHealth Family Medicine - Greeley - Greeley
- UCHealth Medical Center of the Rockies - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-06-23 |
| Est. Completion | 2026-02-09 |
| Phase | Phase 2 |
What the registry record for NCT04963283 still lists
NCT04963283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 7 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04963283 lists 5 locations in 1 state (Colorado).
Frequently Asked Questions
What is clinical trial NCT04963283 about?
NCT04963283 is a clinical study titled "Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer". Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cab...
What is the current status of trial NCT04963283?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-06-23. Estimated completion is 2026-02-09.
What conditions does trial NCT04963283 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Adenocarcinoma, Rectal Adenocarcinoma.
What interventions are being tested in trial NCT04963283?
The interventions under investigation include: Nivolumab (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT04963283?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04963283 being conducted?
This trial has 5 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04963283's enrollment target sits among peer trials
48 277th of 381 higher than 101 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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