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Clinical Trial Finder

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

Program Status

Recruiting

Phase

Phase 2 Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Atezolizumab, Bevacizumab, Fluoropyrimidine, GRT-C901, GRT-R902, Ipilimumab, oxaliplatin

Tags

MSS/ pMMR

Comments

Phase II/ III trial. Randomized: one arm receives standard of care; the other, standard of care and the vaccines.
Vaccines: GRT-C901/GRT-R902, prime and boost of a patient-specific neoantigen cancer vaccine.
Only for patients who are planned for, or have received no more than 1 cycle of first-line treatment fo mCRC, with Folfox in combination with bevacizumab (Avastin).
In the trial, the experimental arm receives 24 weeks of standard of care 1st line chemo and, later, the GRT-C901/GRT-R902 vaccine (6 applications). With the first vaccine application, patients receive also the immunotherapy ipilimumab/ Yervoy (anti CTLA-4). As maintainnace, patients receive the immunotherapy atezolizumab/ Tecentric (anti PD L1)

Exclusion criteria: having BRAFV600E mutated cancer not allowed; MSI-H CRC not allowed.

Location Location Status
United States
University of Alabama at Birmingham
Birmingham, Alabama 35294
Not yet recruiting
Banner MD Anderson
Gilbert, Arizona 85234
Not yet recruiting
Highlands Oncology
Springdale, Arkansas 72762
Recruiting
U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology
Los Angeles, California 90033
Recruiting
University of California - Irvine (UCI)
Orange, California 92697
Recruiting
University of California Los Angeles (UCLA)
Santa Monica, California 90404
Not yet recruiting
Eastern CT Hematology and Oncology Associates (ECHO)
Norwich, Connecticut 06360
Recruiting
Lynn Cancer Institute - Boca Raton Regional Hospital
Boca Raton, Florida 33486
Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
Recruiting
University of Miami
Miami, Florida 33136
Not yet recruiting
Miami Cancer Institute at Baptist Health South Florida (USOR site)
Miami, Florida 33176
Recruiting
Orlando Health
Orlando, Florida 32806
Not yet recruiting
Advanced Research (Oncology & Hemotology Associates of West Broward)
Tamarac, Florida 33321
Recruiting
University of Illinois at Chicago
Chicago, Illinois 60607
Not yet recruiting
Rush University Medical Center
Chicago, Illinois 60612
Not yet recruiting
University of Chicago
Chicago, Illinois 60637
Not yet recruiting
Indiana University
Indianapolis, Indiana 46202
Not yet recruiting
American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817
Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
Recruiting
Astera Cancer Care
East Brunswick, New Jersey 08816
Recruiting
Summit Health
Florham Park, New Jersey 07932
Recruiting
Morristown Medical Center
Morristown, New Jersey 07960
Recruiting
Rutgers
New Brunswick, New Jersey 08903
Recruiting
NYU Langone Health
New York, New York 10016
Recruiting
Columbia University Irving Medical Center
New York, New York 10032
Not yet recruiting
New York Cancer and Blood
Port Jefferson Station, New York 11776
Recruiting
Carolinas Center For Advanced Management of Pain
Pinehurst, North Carolina 28370
Recruiting
Christ Hospital Cancer Center
Cincinnati, Ohio 45229
Recruiting
Sidney Kimmel Medical College at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Not yet recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Not yet recruiting
Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee 37203
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Recruiting
MD Anderson
Houston, Texas 77030
Recruiting
Baylor Scott and White
Temple, Texas 76508
Not yet recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah 84112
Recruiting
University of Virginia
Charlottesville, Virginia 22903
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Not yet recruiting

Inclusion Criteria

Inclusion Criteria:

Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received no more than 1 cycle of first-line treatment in the metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab
Measurable and unresectable 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 in opinion of investigator
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.

Exclusion Criteria

Exclusion Criteria:

Patients with deficient mismatch repair (dMMR) or high levels of 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
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
Pregnant, planning to become pregnant, or nursing.

NCT ID

NCT05141721

Date Trial Added

2021-12-02

Updated Date

2022-10-03