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

March 6, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential research subjects will be identified by members of the patient's treatment team, the protocol investigator or research team. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants. The investigator will use information provided by the patient and/or medical record to confirm that the patient is eligible and contact the patient regarding study enrollment. All eligible patients, regardless of sex and race will be approached for participation. No additional measures, e.g. advertisement, payment to patients, will be employed to recruit patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
10 participants will receive one injection of 18F-BMS-986229 (370 MBq) and will then undergo whole-body PET/CT (80 mA) encompassing the vertex of the skull to the proximal thigh performed at 60 minutes (within the range of 55-70 minutes) postinjection. The scan itself is expected to last about 30 minutes and participants will be asked to remain in the waiting area or dedicated room for an additional 30 minutes post scan. The total time from injection will be 120 minutes. In both cohorts, participants whose treatment includes nivolumab and who have positive tumor localization observed at baseline will be asked to undergo an additional round of imaging.
Drug: 18F-BMS-986229 Injection
Single injection prior to scan
Diagnostic test: PET/CT Scan
Whole-body PET/CT (80 mA)
Cohort 2
25 participants may receive 370 MBq of 18F-BMS-986229 given intravenously and will undergo a single PET/CT scan 60 minutes (within the range of 55-70 minutes) postinjection. The scan itself is expected to last about 30 minutes and participants will be asked to remain in the waiting area or dedicated room for an additional 30 minutes post scan. The total time from injection will be 120 minutes. In both cohorts, participants whose treatment includes nivolumab and who have positive tumor localization observed at baseline will be asked to undergo an additional round of imaging. If the participant agrees, they will receive a second injection while undergoing nivolumab treatment (after at least 2 cycles or 6 weeksof therapy).
Diagnostic test: PET/CT Scan
Whole-body PET/CT (80 mA)
Drug: IV 18F-BMS-986229
370 MBq administered intravenously prior to scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Yelena Janjigian, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2019

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

March 6, 2024

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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