A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer (NCT05141721)
A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson โ Gilbert, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- Banner MD Anderson โ Gilbert, Arizona
- Highlands Oncology โ Springdale, Arkansas
- U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology โ Los Angeles, California
- University of California - Irvine (UCI) โ Orange, California
- University of California Los Angeles (UCLA) โ Santa Monica, California
- Rocky Mountain Cancer Centers - USOR โ Denver, Colorado
- Eastern CT Hematology and Oncology Associates (ECHO) โ Norwich, Connecticut
- Lynn Cancer Institute - Boca Raton Regional Hospital โ Boca Raton, Florida
- University of Miami โ Miami, Florida
- Miami Cancer Institute at Baptist Health South Florida (USOR site) โ Miami, Florida
- Mount Sinai Comprehensive Cancer Center โ Miami Beach, Florida
- Orlando Health โ Orlando, Florida
- Advanced Research (Oncology & Hemotology Associates of West Broward) โ Tamarac, Florida
- University of Illinois at Chicago โ Chicago, Illinois
- University of Chicago โ Chicago, Illinois
- Indiana University โ Indianapolis, Indiana
- University of Kansas Medical Center โ Fairway, Kansas
- Norton Cancer Institute โ Louisville, Kentucky
- American Oncology Partners of Maryland, PA โ Bethesda, Maryland
- Barbara Ann Karmanos Cancer Institute โ Detroit, Michigan
- Comprehensive Cancer Centers of Nevada โ Las Vegas, Nevada
- Astera Cancer Care โ East Brunswick, New Jersey
- Summit Health โ Florham Park, New Jersey
- Morristown Medical Center โ Morristown, New Jersey
- Rutgers โ New Brunswick, New Jersey
๐ Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.