XCancer

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

Description:

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.

Sponsor:

Memorial Sloan Kettering Cancer Center

Contacts:

Yelena Janjigian, MD (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT04161781 - Click here to see study on

ClinicalTrials.gov

BMS-986229

Isotope(s):
Target(s):
  • PD-L1
Inclusion
  • 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.
  • * 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).
  • Age 18 years or older.
Exclusion
  • 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:
  • History of active tuberculosis (Bacillus tuberculosis)
  • * 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
  • Subjects with hypothyroidism (e.g., following Hashimoto syndrome) who are stable with hormone replacement therapy or with psoriasis not requiring systemic treatment
  • Subjects with vitiligo or alopecia