Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
Atezolizumab, Bevacizumab, Fluoropyrimidine, GRT-C901, GRT-R902, Ipilimumab, oxaliplatinTags
MSS/ MMRpComments
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.
Helpful Links
Neoantigen-Directed GRANITE Immunotherapy Improves PFS as Maintenance in MSS mCRC A randomized phase 2 study of an individualized neoantigen-targeting immunotherapy in patients with newly diagnosed metastatic microsatellite stable colorectal cancer (MSS-CRC).Location | Location Status |
---|---|
United States | |
Banner MD Anderson Gilbert, Arizona 85234 |
Active, not recruiting |
Highlands Oncology Springdale, Arkansas 72762 |
Active, not recruiting |
U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology Los Angeles, California 90033 |
Active, not recruiting |
University of California - Irvine (UCI) Orange, California 92697 |
Active, not recruiting |
University of California Los Angeles (UCLA) Santa Monica, California 90404 |
Active, not recruiting |
Rocky Mountain Cancer Centers - USOR Denver, Colorado 80218 |
Active, not recruiting |
Eastern CT Hematology and Oncology Associates (ECHO) Norwich, Connecticut 06360 |
Active, not recruiting |
Lynn Cancer Institute - Boca Raton Regional Hospital Boca Raton, Florida 33486 |
Active, not recruiting |
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida 33140 |
Active, not recruiting |
University of Miami Miami, Florida 33136 |
Active, not recruiting |
Miami Cancer Institute at Baptist Health South Florida (USOR site) Miami, Florida 33176 |
Active, not recruiting |
Orlando Health Orlando, Florida 32806 |
Active, not recruiting |
Advanced Research (Oncology & Hemotology Associates of West Broward) Tamarac, Florida 33321 |
Active, not recruiting |
University of Illinois at Chicago Chicago, Illinois 60607 |
Active, not recruiting |
University of Chicago Chicago, Illinois 60637 |
Active, not recruiting |
Indiana University Indianapolis, Indiana 46202 |
Active, not recruiting |
University of Kansas Medical Center Fairway, Kansas 66205 |
Active, not recruiting |
Norton Cancer Institute Louisville, Kentucky 40202 |
Active, not recruiting |
American Oncology Partners of Maryland, PA Bethesda, Maryland 20817 |
Active, not recruiting |
Barbara Ann Karmanos Cancer Institute Detroit, Michigan 48201 |
Active, not recruiting |
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada 89119 |
Active, not recruiting |
Astera Cancer Care East Brunswick, New Jersey 08816 |
Active, not recruiting |
Summit Health Florham Park, New Jersey 07932 |
Active, not recruiting |
Morristown Medical Center Morristown, New Jersey 07960 |
Active, not recruiting |
Rutgers New Brunswick, New Jersey 08903 |
Active, not recruiting |
NYU Langone Health New York, New York 10016 |
Active, not recruiting |
Columbia University Irving Medical Center New York, New York 10032 |
Active, not recruiting |
New York Cancer and Blood Port Jefferson Station, New York 11776 |
Active, not recruiting |
Christ Hospital Cancer Center Cincinnati, Ohio 45229 |
Active, not recruiting |
Northwest Cancer Specialists DBA Compass Oncology - USOR Portland, Oregon 97227 |
Active, not recruiting |
Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, Pennsylvania 19107 |
Active, not recruiting |
Allegheny General Hospital Pittsburgh, Pennsylvania 15212 |
Active, not recruiting |
Prisma Health Greenville, South Carolina 29615 |
Active, not recruiting |
Tennessee Oncology - Sarah Cannon Research Institute Nashville, Tennessee 37203 |
Active, not recruiting |
Vanderbilt University Medical Center Nashville, Tennessee 37232 |
Active, not recruiting |
Texas Oncology PA - USOR Austin, Texas 78705 |
Active, not recruiting |
Texas Oncology - Dallas Sammons Dallas, Texas 75246 |
Active, not recruiting |
MD Anderson Houston, Texas 77030 |
Active, not recruiting |
Baylor Scott and White Temple, Texas 76508 |
Active, not recruiting |
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah 84112 |
Active, not recruiting |
University of Virginia Charlottesville, Virginia 22903 |
Active, not recruiting |
Virginia Cancer Specialists Fairfax, Virginia 22031 |
Active, not recruiting |
Medical College of Wisconsin Milwaukee, Wisconsin 53226 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria
Exclusion Criteria:
* 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
* 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.