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NCT04599140 · ClinicalTrials.gov registry record · Phase 1
SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial
A Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Rectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT04599140: Active Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Rectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04599140 is a Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Rectal Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04599140, a Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Rectal Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the side effects and best dose of SX-682 that can be given alone and in combination with nivolumab in treating patients with RAS-Mutated, microsatellite stable (MSS) colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). SX-682 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 alone and together with nivolumab may kill more tumor cells.
Primary Outcome
For each system organ class and preferred term, summaries will be made with respect to the number and proportion of subjects having at least 1 occurrence of an adverse event during the study. The incidence of AEs will be presented overall, by system organ class and preferred term, intensity (based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), immune-related adverse events, treatment-emergent adverse events, and additional grouping by severity and relat
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG CXCR1/2 Inhibitor SX-682
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What the registry record for NCT04599140 still lists
NCT04599140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (41% lower).
The record links to 10 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04599140 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04599140 about?
NCT04599140 is a clinical study titled "SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial". This phase Ib/II trial studies the side effects and best dose of SX-682 that can be given alone and in combination with nivolumab in treating patients with RAS-Mutated, microsatellite stable (MSS) colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surg...
What is the current status of trial NCT04599140?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2020-10-14. Estimated completion is 2026-07-31.
What conditions does trial NCT04599140 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC V8, Stage IIIB Rectal Cancer AJCC v8.
What interventions are being tested in trial NCT04599140?
The interventions under investigation include: Nivolumab (BIOLOGICAL), CXCR1/2 Inhibitor SX-682 (DRUG).
Who is sponsoring clinical trial NCT04599140?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04599140 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04599140's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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