Esophagogastric CancerNCT04161781
A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer
An observational study of Esophagogastric Cancer and Esophagus Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Cancer, Esophagus Cancer, Esophageal Cancer
- What is being tested?
- 18F-BMS-986229 Injection, IV 18F-BMS-986229 and PET/CT Scan
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 6 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Esophagogastric Cancer, Esophagus Cancer, Esophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Being tested
- 18F-BMS-986229 Injection, IV 18F-BMS-986229, PET/CT Scan
- Keywords
- 18F-BMS-986229, Memorial Sloan Kettering Cancer Center, 19-122
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-BMS-986229 InjectionDrug
Single injection prior to scan
IV 18F-BMS-986229Drug
370 MBq administered intravenously prior to scan
PET/CT ScanDiagnostic test
Whole-body PET/CT (80 mA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-BMS-986229 Injection; Diagnostic Test: PET/CT Scan | |
| 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). Receives: Drug: IV 18F-BMS-986229; Diagnostic Test: PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start12 Nov 2019
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagogastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Yelena Janjigian, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161781
- Sponsor's protocol ID
- 19-122
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38514081
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of 18F-BMS-986229 PET in Esophagogastric Cancer
- ClinicalTrials.gov ID
- NCT04161781
- Acronym / sponsor ID
- 19-122
- Conditions
- Esophagogastric Cancer, Esophagus Cancer, Esophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Keywords
- 18F-BMS-986229, Memorial Sloan Kettering Cancer Center, 19-122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: 18F-BMS-986229 Injection, Diagnostic Test: PET/CT Scan10 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 | – | Drug: IV 18F-BMS-986229, Diagnostic Test: PET/CT Scan25 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-BMS-986229 InjectionSingle injection prior to scan | Drug | Cohort 1 |
| IV 18F-BMS-986229370 MBq administered intravenously prior to scan | Drug | Cohort 2 |
| PET/CT ScanWhole-body PET/CT (80 mA) | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 38514081Cytryn 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Janjigian, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagogastric Cancer and Esophagus Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.