๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-13

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

๐Ÿ”ต Active, Not Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Seattle Project Corporation

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—