A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stom… (NCT04161781) | Clinical Trial Compass
CompletedNot Applicable
A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer
United States10 participantsStarted 2019-11-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer