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NCT03657641 · ClinicalTrials.gov registry record · Phase 1
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
A Phase 1 study of Colorectal Cancer and Colorectal Cancer Metastatic, sponsored by University of Southern California.
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 3
- Study locations
NCT03657641: Active Phase 1 study of Colorectal Cancer and Colorectal Cancer Metastatic, sponsored by University of Southern California.
NCT03657641 is a Phase 1 study of Colorectal Cancer and Colorectal Cancer Metastatic that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 75 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657641, a Phase 1 study of Colorectal Cancer and Colorectal Cancer Metastatic, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.
Primary Outcome
Number of patients that required a dose modification while on study treatment, due to a Dose limiting toxicity (DLT), during Phase I and Phase II. DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 and is defined in the study protocol section 6.2.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Regorafenib
Study Locations (3)
California
- City of Hope - Duarte
- USC / Norris Comprehensive Cancer Center - Los Angeles
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2026-06-21 |
| Phase | Phase 1 |
What the registry record for NCT03657641 still lists
NCT03657641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03657641 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT03657641 about?
NCT03657641 is a clinical study titled "Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer". This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumo...
What is the current status of trial NCT03657641?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2019-06-21. Estimated completion is 2026-06-21.
What conditions does trial NCT03657641 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colorectal Cancer Metastatic.
What interventions are being tested in trial NCT03657641?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Regorafenib (DRUG).
Who is sponsoring clinical trial NCT03657641?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03657641 being conducted?
This trial has 3 study locations across California, Florida. 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 NCT03657641's enrollment target sits among peer trials
75 239th of 381 higher than 143 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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