Using Genetic Testing to Choose the Best Treatment for Advanced or Metastatic Clear Cell Kidney Cancer OPTIC RCC Phase II Study

What this Trial Is About

Researchers are evaluating whether genetic testing of tumor tissue can help select the best treatment for patients with advanced or metastatic clear cell renal cell carcinoma kidney cancer. This phase II trial focuses on two FDA-approved treatment combinations one with two immunotherapy drugs given by intravenous infusion nivolumab plus ipilimumab and another combining one immunotherapy infusion nivolumab with an oral targeted therapy pill cabozantinib. The study aims to see if matching treatment to the tumors genetic makeup can improve treatment response. Participants are assigned to one of two treatment arms based on the tumors RNA sequencing results. In Arm I, patients receive ipilimumab and nivolumab infusions every 21 days for four cycles, followed by nivolumab maintenance infusions every 4 weeks if there is no disease progression or unacceptable side effects. In Arm II, patients receive nivolumab infusion on day 1 and take cabozantinib pills daily, with cycles repeating every 4 weeks under similar conditions. After treatment, patients are followed up within 30 days of the last dose. During the study, participants will have tumor tissue tested for genetic clusters to guide treatment choice. Researchers will monitor treatment response using overall response rates and progression-free survival, assess side effects including immune-related events, and analyze tissue and blood samples to understand treatment effects. The trial may last up to four years, with regular treatment cycles and follow-up visits to evaluate patient outcomes and safety.

Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study