A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer

Study Overview
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Brief Summary
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The purpose of the study is to test 18F-BMS-986229 positron emission tomography (PET) imaging a practical and safe way to check the status of esophageal, stomach, and gastroesophageal junction cancer.

Official Title
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Pilot Trial of 18F-BMS-986229 PET in Esophagogastric Cancer

Conditions
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Esophagogastric Cancer, Esophagus Cancer, Esophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastroesophageal Junction Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: 18F-BMS-986229 Injection
* Drug: IV 18F-BMS-986229
* Diagnostic Test: PET/CT Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must have pathologically or cytolofically confirmed (at 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). Participants must have disease that can be evaluated radiographically. This may be measurable disease or nonmeasurable disease according to RECIST 1.1. Concurrent therapy is allowed. Age 18 years or older. 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. Hematological Absolute neutrophil count: >/=1,000/mCL Platelets: >/=90,000/mCL Hemoglobin: >/=8 g/dL Renal Serum creatinine: </=2.0 x upper limit of normal (ULN) Hepatic 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]) AST (SGOT) and ALT (SGPT): </=2.5 x ULN OR </=5 x ULN for subjects with liver metastases 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 erythematous, Wegener syndrome [granulomatosis with polyangitis], 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>10 participants will receive one injection of 18F-BMS-986229 (370 MBq) and will then undergo whole-body PET/CT (80 mA) encompassing the vertex of the skull to the proximal thigh performed at 60 minutes (within the range of 55-70 minutes) postinjection. The scan itself is expected to last about 30 minutes and participants will be asked to remain in the waiting area or dedicated room for an additional 30 minutes post scan. The total time from injection will be 120 minutes. In both cohorts, participants whose treatment includes nivolumab and who have positive tumor localization observed at baseline will be asked to undergo an additional round of imaging. | Drug: 18F-BMS-986229 Injection<br>* Single injection prior to scan<br>Diagnostic Test: PET/CT Scan<br>* Whole-body PET/CT (80 mA)<br>|
| Cohort 2<br>25 participants may receive 370 MBq of 18F-BMS-986229 given intravenously and will undergo a single PET/CT scan 60 minutes (within the range of 55-70 minutes) postinjection. The scan itself is expected to last about 30 minutes and participants will be asked to remain in the waiting area or dedicated room for an additional 30 minutes post scan. The total time from injection will be 120 minutes. In both cohorts, participants whose treatment includes nivolumab and who have positive tumor localization observed at baseline will be asked to undergo an additional round of imaging. If the participant agrees, they will receive a second injection while undergoing nivolumab treatment (after at least 2 cycles or 6 weeksof therapy). | Drug: IV 18F-BMS-986229<br>* 370 MBq administered intravenously prior to scan<br>Diagnostic Test: PET/CT Scan<br>* Whole-body PET/CT (80 mA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer | 18F-BMS-986229 PET will be considered feasible if there are no Grade 3 or higher 18F-BMS-986229 related adverse events and if at least 7 to 10 participants in Cohort 1 (70%) are found to be 18F-BMS-986229 PET positive. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-BMS-986229, Memorial Sloan Kettering Cancer Center, 19-122