Esophageal Cancer, Esophagogastric Cancer, Esophagus Cancer, Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Gastroesophageal Junction Squamous Cell Carcinoma
Conditions
Keywords
18F-BMS-986229, Memorial Sloan Kettering Cancer Center, 19-122
Brief summary
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.
Interventions
DRUGIV 18F-BMS-986229
370 MBq administered intravenously prior to scan
DIAGNOSTIC_TESTPET/CT Scan
Whole-body PET/CT (80 mA)
DRUG18F-BMS-986229 Injection
Single injection prior to scan
Sponsors
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer | 4 weeks | 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. |
Countries
United States
Outcome results
None listed