A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer
Pilot Trial of 18F-BMS-986229 PET in Esophagogastric Cancer
1 other identifier
observational
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2019
CompletedStudy Start
First participant enrolled
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2024
CompletedMay 16, 2025
March 1, 2024
4.3 years
November 12, 2019
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
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).
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Cytryn SL, Pandit-Taskar N, Lumish MA, Maron SB, Gu P, Ku GY, Chou JF, Capanu M, Antoine A, Loegel D, Feder L, Philemond S, Lyashchenko SK, Lewis JS, Paroder V, Srivastava A, Tang LH, Schoder H, Janjigian YY. 18F-BMS-986229 PET to Assess Programmed-Death Ligand 1 Status in Gastroesophageal Cancer. J Nucl Med. 2024 May 1;65(5):722-727. doi: 10.2967/jnumed.123.267186.
PMID: 38514081DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yelena Janjigian, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 13, 2019
Study Start
November 12, 2019
Primary Completion
March 6, 2024
Study Completion
March 6, 2024
Last Updated
May 16, 2025
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
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.