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NCT05141721 · ClinicalTrials.gov registry record · Phase 2
A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
A Phase 2 study of Colorectal Neoplasms, sponsored by Seattle Project Corporation.
- Active
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT05141721 is a Phase 2 study of Colorectal Neoplasms that is active but no longer recruiting, run by Seattle Project Corporation. The registered enrollment target is 700 participants, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05141721, a Phase 2 study of Colorectal Neoplasms, is active but no longer recruiting, sponsored by Seattle Project Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus a fluoropyrimidine/bevacizumab alone as assessed by molecular response which is based on changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regimen as assessed by progression-free survival.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Ipilimumab
- DRUG GRT-C901
- DRUG GRT-R902
- DRUG Fluoropyrimidine plus leucovorin
Study Locations (20)
Florida
- Lynn Cancer Institute - Boca Raton Regional Hospital - Boca Raton
- University of Miami - Miami
- Miami Cancer Institute at Baptist Health South Florida (USOR site) - Miami
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Orlando Health - Orlando
- Advanced Research (Oncology & Hemotology Associates of West Broward) - Tamarac
California
- U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology - Los Angeles
- University of California - Irvine (UCI) - Orange
- University of California Los Angeles (UCLA) - Santa Monica
Illinois
- University of Illinois at Chicago - Chicago
- University of Chicago - Chicago
Arizona
- Banner MD Anderson - Gilbert
Arkansas
- Highlands Oncology - Springdale
Colorado
- Rocky Mountain Cancer Centers - USOR - Denver
Connecticut
- Eastern CT Hematology and Oncology Associates (ECHO) - Norwich
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2022-02-12 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05141721
The ClinicalTrials.gov registry entry for NCT05141721 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher). The listed sponsor is Seattle Project Corporation, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05141721 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05141721 about?
NCT05141721 is a clinical study titled "A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer". The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus a fluoropyrimidine/bevacizumab alo...
What is the current status of trial NCT05141721?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2022-02-12. Estimated completion is 2027-03.
What conditions does trial NCT05141721 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT05141721?
The interventions under investigation include: Atezolizumab (DRUG), Ipilimumab (DRUG), GRT-C901 (DRUG), GRT-R902 (DRUG), Fluoropyrimidine plus leucovorin (DRUG).
Who is sponsoring clinical trial NCT05141721?
This trial is sponsored by Seattle Project Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05141721 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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