The purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and bad) of cemiplimab either alone or combined with fianlimab has on patients with oligometastatic clear cell renal cell carcinoma after completion of radiation therapy.
Patient must be >= 18 years of age.
Patient must have a biopsy/pathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to randomization.
Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to randomization.
Patients with untreated brain metastasis measuring <2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological symptoms. Patients with treated brain metastasis are eligible for the trial as long as they have had three or fewer brain metastasis without signs of progression of disease on post-treatment MRI of the brain as per RANO for Brain Metastases (RANO-BM) guidelines.
Patients with untreated brain metastasis >2cm, significant neurological deficits and unamenable to surgical resection.
Patient with variant histology renal cell carcinoma.
Patient with metastasis invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum).
Patients with more than 2 liver metastatic lesions, or liver lesions resulting in obstructive jaundice.
University of Oklahoma
Lead sponsor
Regeneron Pharmaceuticals
Collaborator