Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
Fruquintinib, TislelizumabTags
MSS/ MMRpComments
Only for MSS CRC patients. No prior immunotherapy allowed.
Fruquintinib (oral) in combination with Tislelizumab (intravenous).
Fruquintinib: small-molecule inhibitor of VEGFR-1, -2 and -3. It is in Phase III clinical trials. UPDATE: FDA-approved as part of the standard of care for CRC (november 2323; see Helpful Links)
Tislelizumab: immunotherapy, PD-1 checkpoint inhibitor.
Helpful Links
https://www.annalsofoncology.org/article/S0923-7534(22)03899-6/fulltext https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancerLocation | Location Status |
---|---|
United States | |
Mayo Clinic Arizona Phoenix, Arizona 85054 |
Active, not recruiting |
Highlands Oncology Springdale, Arkansas 72762 |
Active, not recruiting |
Beverly Hills Cancer Center Beverly Hills, California 90211 |
Active, not recruiting |
University of Colorado Aurora, Colorado 80045 |
Active, not recruiting |
Florida Cancer Specialists - FCS South Port Charlotte, Florida 33980 |
Active, not recruiting |
Florida Cancer Center North Saint Petersburg, Florida 33709 |
Active, not recruiting |
Florida Cancer Specialists Panhandle Tallahassee, Florida 32308 |
Active, not recruiting |
Florida Cancer Specialists - East (FCS East) West Palm Beach, Florida 33401 |
Active, not recruiting |
HOC AON Baton Rouge / Sarah Cannon Baton Rouge, Louisiana 70809 |
Active, not recruiting |
Messino Cancer Center Asheville, North Carolina 28806 |
Active, not recruiting |
Oklahoma University Stephenson Cancer Center Oklahoma City, Oklahoma 73104 |
Active, not recruiting |
Women and Infants Hospital of Rhode Island Providence, Rhode Island 02905 |
Active, not recruiting |
Tennessee Oncology-Chattanooga Chattanooga, Tennessee 37404 |
Active, not recruiting |
Tennesse Oncology Nashville, Tennessee 37203 |
Active, not recruiting |
Vanderbilt Ingram Cancer Center Nashville, Tennessee 37232 |
Active, not recruiting |
The University of Texas MD Anderson Cancer Center Houston, Texas 77030 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines;
Age ≥18 years;
Histologically or cytologically documented, advanced or metastatic Triple Negative Breast Cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum.
Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
At least 1 measurable lesion as defined by RECIST v1.1.
Exclusion Criteria
Exclusion Criteria:
Has at screening any central nervous system metastasis and/or leptomeningeal disease.
Except for Cohort A, Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).
Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab).
Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply