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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161781
• Other study ID #: 19-122
• Status: Completed
• Start date: November 12, 2019
• Est. completion date: March 6, 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Esophagogastric Cancer
• Esophagus Cancer
• Gastric Adenocarcinoma
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Gastroesophageal Junction Squamous Cell Carcinoma

Intervention

Drug:
• 18F-BMS-986229 Injection
Single injection prior to scan
• IV 18F-BMS-986229
370 MBq administered intravenously prior to scan

Diagnostic Test:
• PET/CT Scan
Whole-body PET/CT (80 mA)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center