GRT-C901: A patient-specific neoantigen cancer vaccine administered via intramuscular (IM) injection as prime and single boost at a dose of 1x10\^12 viral particles 2 times over the course of the first year.
GRT-R902: A patient-specific neoantigen cancer vaccine boost, administered via IM injection at a dose of 30ug 4 times over the course of the first year.
Atezolizumab: Atezolizumab will be administered via intravenous (IV) infusion at a dose of 1680 mg once every 4 weeks.
Ipilimumab: Ipilimumab will be administered via subcutaneous (SC) injection at a dose of 30 mg with the first dose of GRT-C901 and GRT-R902.
Fluoropyrimidine plus leucovorin: Fluoropyrimidine (infusional 5-FU or capecitabine) and leucovorin administered as maintenance therapy per standard of care.
Bevacizumab: Bevacizumab administered as maintenance therapy per standard of care.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | |
| Highlands Oncology | Springdale | Arkansas | |
| U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology | Los Angeles | California | |
| University of California - Irvine (UCI) | Orange | California | |
| University of California Los Angeles (UCLA) | Santa Monica | California | |
| Rocky Mountain Cancer Centers - USOR | Denver | Colorado | |
| Eastern CT Hematology and Oncology Associates (ECHO) | Norwich | Connecticut | |
| Lynn Cancer Institute - Boca Raton Regional Hospital | Boca Raton | Florida | |
| University of Miami | Miami | Florida | |
| Miami Cancer Institute at Baptist Health South Florida (USOR site) | Miami | Florida | |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | |
| Orlando Health | Orlando | Florida | |
| Advanced Research (Oncology & Hemotology Associates of West Broward) | Tamarac | Florida | |
| University of Illinois at Chicago | Chicago | Illinois | |
| University of Chicago | Chicago | Illinois | |
| Indiana University | Indianapolis | Indiana | |
| University of Kansas Medical Center | Fairway | Kansas | |
| Norton Cancer Institute | Louisville | Kentucky | |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| Summit Health | Florham Park | New Jersey | |
| Morristown Medical Center | Morristown | New Jersey | |
| Rutgers | New Brunswick | New Jersey | |
| NYU Langone Health | New York | New York | |
| Columbia University Irving Medical Center | New York | New York | |
| New York Cancer and Blood | Port Jefferson Station | New York | |
| Christ Hospital Cancer Center | Cincinnati | Ohio | |
| Northwest Cancer Specialists DBA Compass Oncology - USOR | Portland | Oregon | |
| Sidney Kimmel Medical College at Thomas Jefferson University | Philadelphia | Pennsylvania | |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | |
| Prisma Health | Greenville | South Carolina | |
| Tennessee Oncology - Sarah Cannon Research Institute | Nashville | Tennessee | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Texas Oncology PA - USOR | Austin | Texas | |
| Texas Oncology - Dallas Sammons | Dallas | Texas | |
| MD Anderson | Houston | Texas | |
| Baylor Scott and White | Temple | Texas | |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
+ 3 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05141721 on ClinicalTrials.gov ↗ ← All trials in the USA