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Colorectal NeoplasmsPhase 2/3NCT05141721

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

A Phase 2/3 study testing GRT-C901, GRT-R902 and Atezolizumab in people with Colorectal Neoplasms, run by Seattle Project Corporation at 43 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
GRT-C901, GRT-R902 and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
43 sitesUnited States
Study dates
12 Feb 2022to Mar 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received <30 days of first-line treatment in the metastatic setting with FOLFOX/bev, CAPEOX/bev, FOLFOXIRI/bev, or CAPOXIRI/bev per SOC
  • Measurable and unresectable metastatic disease according to RECIST v1.1
  • Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient has adequate organ function per defined criteria
  • If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 150 days after last investigational study treatment.

Who cannot join

  • Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
  • Patient has a known tumor mutation burden <1 non-synonymous mutations/megabase
  • Known DNA Polymerase Epsilon mutations
  • Patients with known BRAFV600E mutations
  • Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws
  • Immunosuppression anticipated at time of study treatment
Show all 15Show fewer
  • History of allogeneic tissue/solid organ transplant
  • Active or history of autoimmune disease or immune deficiency
  • Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation
  • History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy
  • Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study
  • Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV
  • History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
  • Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (Class III or IV).
  • Pregnant, planning to become pregnant, or nursing.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Texas Oncology PA - USOR

    Austin, Texas, 78705

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • Lynn Cancer Institute - Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Illinois at Chicago

    Chicago, Illinois, 60607

  • University of Chicago

    Chicago, Illinois, 60637

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45229

  • Texas Oncology - Dallas Sammons

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers - USOR

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • University of Kansas Medical Center

    Fairway, Kansas, 66205

  • Summit Health

    Florham Park, New Jersey, 07932

  • Banner MD Anderson

    Gilbert, Arizona, 85234

  • Prisma Health

    Greenville, South Carolina, 29615

  • MD Anderson

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119

  • U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology

    Los Angeles, California, 90033

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • 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

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Tennessee Oncology - Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers

    New Brunswick, New Jersey, 08903

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Eastern CT Hematology and Oncology Associates (ECHO)

    Norwich, Connecticut, 06360

  • University of California - Irvine (UCI)

    Orange, California, 92697

  • Orlando Health

    Orlando, Florida, 32806

  • Sidney Kimmel Medical College at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • New York Cancer and Blood

    Port Jefferson Station, New York, 11776

  • Northwest Cancer Specialists DBA Compass Oncology - USOR

    Portland, Oregon, 97227

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • University of California Los Angeles (UCLA)

    Santa Monica, California, 90404

  • Highlands Oncology

    Springdale, Arkansas, 72762

  • Advanced Research (Oncology & Hemotology Associates of West Broward)

    Tamarac, Florida, 33321

  • Baylor Scott and White

    Temple, Texas, 76508

Other trials in United States

About this study

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

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.

Read the detailed description

Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of human leukocyte antigens (HLAs) on the tumor cell surface. A fraction of mutated peptides result in neoantigens capable of generating T-cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a patient-specific cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901 first followed by GRT-R902) to stimulate an immune response. This study will explore the anti-tumor activity of this patient-specific immunotherapy in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab.

Being tested
GRT-C901, GRT-R902, Atezolizumab, Ipilimumab, Fluoropyrimidine plus leucovorin
Keywords
Colorectal cancer vaccine, mCRC, colon, rectum, CRC, rectal, immunotherapy, MSS-CRC, personal cancer vaccine, personalized cancer vaccine, individualized cancer vaccine
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GRT-C901Drug

    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-R902Drug

    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.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered via intravenous (IV) infusion at a dose of 1680 mg once every 4 weeks.

  • IpilimumabDrug

    Also called Yervoy

    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 leucovorinDrug

    Also called Xeloda

    Fluoropyrimidine (infusional 5-FU or capecitabine) and leucovorin administered as maintenance therapy per standard of care.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab administered as maintenance therapy per standard of care.

Study groups in NCT05141721
Study groupRoleWhat they receive
Vaccine ArmExperimentalAfter receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and after completing vaccine production screening, patients will receive a total of 6 administrations of GRT-C901/GRT-R902 plus ipilimumab co-administered only with the first dose of GRT-C901 and GRT-R902. All patients will receive atezolizumab in addition to maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.
Receives: Drug: GRT-C901; Drug: GRT-R902; Drug: Atezolizumab; Drug: Ipilimumab; Drug: Fluoropyrimidine plus leucovorin; Drug: Bevacizumab
Control ArmActive comparatorAfter receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and undergoing vaccine production screening, patients will receive maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.
Receives: Drug: Fluoropyrimidine plus leucovorin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2: Molecular response defined as ≥ 30% decrease from baseline in circulating tumor DNA (ctDNA)

    Measured: Baseline and up to 27 months

  2. Phase 3: Progression-free survival per Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by blinded independent review committee (IRC)

    defined by time from randomization until disease progression as per iRECIST or death from any cause

    Measured: Up to 60 months

Secondary outcomes (9)

  1. Phase 2 and 3: Incidence of treatment-emergent adverse events (TEAEs), immune-related AEs, treatment-related AEs, serious AEs, AEs leading to death, AEs leading to dose delays, and AEs leading to discontinuation of study treatment

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  2. Phase 2 and 3: Progression-free survival per RECIST v1.1 and iRECIST as assessed by the investigator

    Measured: Phase 2: up to 27 months, Phase 3: up to 60 months

  3. Phase 3: Progression-free survival per RECIST v1.1 as assessed by blinded IRC

    Measured: Up to 60 months

  4. Phase 2 and 3: Overall Survival as time from randomization to death from any cause

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  5. Phase 2 and 3: Overall Response Rate

    measured by the proportion of patients with best overall response (BOR) of partial response (PR) or complete response (CR) by REICST v1.1 or , immune-based PR (iPR) or immune-based by iRECIST

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  6. Phase 2 and 3: Duration of response (DOR) defined by time from the first objective response of PR or PR until disease progression or death

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  7. Phase 2 and 3: Clinical benefit rate (CBR) as defined by the proportion of patients with best overall response of stable disease (SD), PR or CR using RECIS v1.1 or immune-based SD (iSD), iPR, or iCR by iRECIST.

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  8. Phase 2 and 3: Deepening of Response the proportion of patients who have a BOR of SD or PR during the VPS and who convert from SD to PR or CR, or from PR to CR after start of the study treatment and/or SOC maintenance treatment in the STS per RECIST v1.1

    VPS = Vaccine Production Stage; STS = Study Treatment Stage

    Measured: Phase 2 up to 27 months, Phase 3 up to 60 months

  9. Phase 2 and 3: The feasibility of manufacturing a patient-specific vaccine defined by the proportion of patients for whom vaccine was successfully manufactured from those randomized to the vaccine arm.

    Measured: Study Treatment Screening visit (up to 28 days before Day 1 of study drug administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start12 Feb 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141721
Sponsor's protocol ID
GO-010
Status last verified
May 2025
First submitted
19 Nov 2021
Last updated
16 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GRT-C901, GRT-R902 and Atezolizumab in people with Colorectal Neoplasms, run by Seattle Project Corporation at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2: Molecular response defined as ≥ 30% decrease from baseline in circulating tumor DNA (ctDNA) (time frame: Baseline and up to 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05141721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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