This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab.
This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab. Subjects with advanced unresectable or metastatic gastroesophageal adenocarcinoma are eligible. All subjects will receive FOLFOX + nivolumab therapy. Subjects who demonstrate at least stable disease, as per RECIST 1.1, on their first imaging assessment at two months will receive one additional month of FOLFOX + nivolumab (3 months total), and then will be randomly assigned at a 1:1 ratio to receive either nivolumab alone or nivolumab plus radiation therapy. Radiation therapy fields and technique will be approved by central review. Radiation will be planned at 4Gy x 5 doses (20 Gy total), given concurrently with nivolumab. After 4 months of therapy, patients who remain on study will receive nivolumab 480 mg every 4 weeks. Subjects will be on study (intervention + follow-up) for approximately 24 months. The projected end date of the study, including data analysis, is February 2026.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
Moffitt Cancer Center
Tampa, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Number of Patients With 12-month Progression Free Survival in Each Arm
This will be measured by number of patients without disease progression at 12 months in the two study arms (patients who receive nivolumab with radiation and those who receive nivolumab alone)
Time frame: 12 months
Amongst All Randomized Subjects, the Number of Subjects That Achieved 12-month Progression Free Survival
This will be measured by the number of patients without disease progression at 12 months in all enrolled patients.
Time frame: 12 months
Amongst All Randomized Subjects, Overall Survival, as Measured by the Rate of Survival in Patients, at 1-year
In both study arms, we will examine the rate of survival in patients over time from registration through their treatment
Time frame: 1 year
Occurrence of Significant Toxicity, as Measured by Rate of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to Immunotherapy Per the Study Cohort
We will measure the rate of grade 3 or 4 adverse events attributable to immunotherapy in both study arms
Time frame: 2 year
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Weill Cornell Medicine
New York, New York, United States