A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT05141721. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05141721
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Interventions
- GRT-C901 Drug
- GRT-R902 Drug
- Atezolizumab Drug
- Ipilimumab Drug
- Fluoropyrimidine plus leucovorin Drug
- Bevacizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 12, 2022 (Actual)
- Primary completion
- Mar 2027 (Estimated)
- Completion
- Mar 2027 (Estimated)
- Last update posted
- May 16, 2025
2022 – 2027
United States locations
- U.S. sites
- 43
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | — |
| Highlands Oncology | Springdale | Arkansas | 72762 | — |
| U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology | Los Angeles | California | 90033 | — |
| University of California - Irvine (UCI) | Orange | California | 92697 | — |
| University of California Los Angeles (UCLA) | Santa Monica | California | 90404 | — |
| Rocky Mountain Cancer Centers - USOR | Denver | Colorado | 80218 | — |
| Eastern CT Hematology and Oncology Associates (ECHO) | Norwich | Connecticut | 06360 | — |
| Lynn Cancer Institute - Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Miami Cancer Institute at Baptist Health South Florida (USOR site) | Miami | Florida | 33176 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Advanced Research (Oncology & Hemotology Associates of West Broward) | Tamarac | Florida | 33321 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60607 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89119 | — |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | — |
| Summit Health | Florham Park | New Jersey | 07932 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers | New Brunswick | New Jersey | 08903 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| New York Cancer and Blood | Port Jefferson Station | New York | 11776 | — |
| Christ Hospital Cancer Center | Cincinnati | Ohio | 45229 | — |
| Northwest Cancer Specialists DBA Compass Oncology - USOR | Portland | Oregon | 97227 | — |
| Sidney Kimmel Medical College at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Prisma Health | Greenville | South Carolina | 29615 | — |
| Tennessee Oncology - Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology PA - USOR | Austin | Texas | 78705 | — |
| Texas Oncology - Dallas Sammons | Dallas | Texas | 75246 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| Baylor Scott and White | Temple | Texas | 76508 | — |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05141721, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05141721 live on ClinicalTrials.gov.