Phase
Condition
Non-small Cell Lung Cancer
Neuroblastoma
Pancreatitis
Treatment
ipilimumab
nivolumab
GRT-R904
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:
- Microsatellite-stable colorectal cancer (MSS-CRC) who are currently receivingsystemic treatment with a fluoropyrimidine and oxaliplatin and/or irinotecan thatmay include a VEGF or EGFR targeting therapy as their 1L therapy for metastaticdisease OR who have experienced disease progression following treatment with afluoropyrimidine, oxaliplatin, and irinotecan that may include a VEGF or EGFRtargeting therapy and have not received additional lines of systemic therapy inthe metastatic setting.
- Non-small cell lung cancer (NSCLC) who are currently receiving systemic treatmentwith an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-basedchemotherapy OR who have experienced disease progression following treatment withan anti-PD-(L)1 antibody in combination with cytotoxic, platinum-basedchemotherapy (or anti-PD-(L)1 alone if patient refuses platinum-basedchemotherapy), and have not received additional lines of systemic therapy in themetastatic setting.
- Pancreatic ductal adenocarcinoma (PDA) who are currently receiving systemiccytotoxic chemotherapy as their 1L therapy for metastatic disease OR who haveexperienced disease progression on 1L systemic cytotoxic chemotherapy and havereceived no more than 1 prior line of therapy in the metastatic setting.
- Any solid tumor histology where the patient has experienced disease progressionwith all available therapies known to confer clinical benefit
- Patient's tumor possesses one of the mutations listed below, and is determined toexpress a HLA allele for antigen presentation of the identified tumor mutation: VERSION 1.0 of the expression cassette: BRAF_G466V // CTNNB1_S37F // CTNNB1_S45F // CTNNB1_S45P // CTNNB1_T41A //ERBB2_Y772_A775dup // KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V //KRAS_G13D // KRAS_Q61H or NRAS_Q61H // KRAS_Q61K or NRAS_Q61K // KRAS_Q61L or NRAS_Q61L //KRAS_Q61R or NRAS_Q61R // TP53_K132E // TP53_K132N // TP53_R213L // TP53_R249M //TP53_S127Y VERSION 2.0 of the expression cassette: KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V or NRAS_G12V // KRAS_Q61H orNRAS_Q61H
- ECOG Performance Status 0 or 1
- Measurable disease according to RECIST v1.1
- 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
- Patients with known MSI-high disease based on institutional standard
- Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to avaccination
- Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significantbruising or bleeding following IM injections or blood draws
- History of allogenic/solid organ transplant
- Active, known, or suspected autoimmune disease
- Active tuberculosis or recent (<2 week) clinically significant infection, or evidenceof active hepatitis B or hepatitis C
- Known history of positive test for human immunodeficiency (HIV) or known acquiredimmunodeficiency syndrome (AIDS) Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Study Design
Study Description
Connect with a study center
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesSite Not Available
UCLA Medical Center
Santa Monica, California 90404
United StatesSite Not Available
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
University of Chicago Medicine, Comprehensive Cancer Center
Chicago, Illinois 60637
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
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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