Phase
Condition
Colorectal Cancer
Urothelial Carcinoma
Colon Cancer; Rectal Cancer
Treatment
ipilimumab
GRT-C901
nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specificprocedures.
- Patients with the indicated advanced or metastatic solid tumor as follows:
- NSCLC who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy (note: patients who havereceived anti-PD-(L)1 monotherapy are eligible)
- GEA who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy
- mUC who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy
- CRC-MSS who are receiving first line systemic therapy or who are planned for orhave received no more than 1 cycle of second line systemic therapy including afluoropyrimidine and oxaliplatin or irinotecan
- 18 years of age or older
- ECOG Performance Status 0 or 1
- Lesion amenable to biopsy
- Measurable disease according to RECIST v1.1
- Have adequate organ function, as measured by laboratory values (criteria listed inprotocol)
Exclusion
Exclusion Criteria:
- Tumors with genetic characteristics as follows:
- For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1,RET, or TRK
- For CRC and GEA, patients with known MSI-high disease based on institutionalstandard
- For CRC, patients with a known BRAF V600E mutation or patients with peritonealcarcinomatosis and for GEA, patients with peritoneal carcinomatosis as their onlyevidence of disease
- Patients with known central nervous system (CNS) metastases and/or carcinomatousmeningitis
- Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to avaccination or allergy or hypersensitivity to study drug components
- Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significantbruising or bleeding following IM injections or blood draws Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Study Design
Study Description
Connect with a study center
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
The University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10017
United StatesSite Not Available
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available

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