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ACTIVE NOT RECRUITING Phase 2

A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer

NCT05141721 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 700 participants
Start Date 2022-02-12
Est. Completion 2027-03
Phase Phase 2

Sponsor

Seattle Project Corporation

1 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Project Corporation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05141721 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05141721?

This trial is sponsored by Seattle Project Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial