Clinical trial NCT04161781: A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer
Official title: Pilot Trial of 18F-BMS-986229 PET in Esophagogastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagogastric Cancer
Esophagus Cancer
Esophageal Cancer
Gastric Cancer
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Gastroesophageal Junction Squamous Cell Carcinoma
Keywords: 18F-BMS-986229
Memorial Sloan Kettering Cancer Center
19-122
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of 18F-BMS-986229 PET in participants with Gastroesophageal Cancer
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yelena Janjigian, MD
role: PRINCIPAL_INVESTIGATOR
References: