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Completed

NCT Number: NCT04161781

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-BMS-986229 Injection

Drug

Single injection prior to scan

IV 18F-BMS-986229

Drug

370 MBq administered intravenously prior to scan

PET/CT scan

Diagnostic Test

Whole-body PET/CT (80 mA)

Primary outcomes

  1. Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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