18F-BMS-986229 PET for the Diagnosis of Esophagogastric Cancer

Inclusion Criteria

• Patient must have pathologically or cytologically confirmed (at Memorial Sloan Kettering [MSK]) esophageal, gastric, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma
• PD-L1 – positive expression in >= 1% of the tumor or stromal cells. PD-L1 expression will be reviewed by MSK pathologist, scored and recorded using the combined positive score (CPS) formula (number of PD-L1 positive tumor cells, lymphocytes, and macrophages divided by the number of tumor cells x 100)
• Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Concurrent therapy is allowed
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before receiving the first dose of the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Adequate organ function, as defined in Table 1. All screening labs should be performed within 14 days of initiation of treatment
• Absolute neutrophil count >= 1,000/mcL (performed within 14 days of initiation of treatment)
• Platelets >= 90,000/mcL (performed within 14 days of initiation of treatment)
• Hemoglobin >= 8 g/dL (performed within 14 days of initiation of treatment)
• Serum creatinine =< 2.0 x upper limit of normal (ULN) (performed within 14 days of initiation of treatment)
• Serum total bilirubin =< 2.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR (except patients with Gilbert’s disease [=< 3 x ULN]) (performed within 14 days of initiation of treatment)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (performed within 14 days of initiation of treatment)

Exclusion Criteria

• Known diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment
• History of active tuberculosis (Bacillus tuberculosis)
• Active or documented autoimmune or inflammatory disorder (including inflammatory bowel disease, systemic lupus erythematosus, Wegener syndrome [granulomatosis with polyangiitis], myasthenia gravis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis) within the 3 years before the start of treatment. The following are exceptions to this criterion: * Subjects with vitiligo or alopecia * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) who are stable with hormone replacement therapy or with psoriasis not requiring systemic treatment