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

Description

PRIMARY OBJECTIVE:

I. To improve objective response rate of front-line therapy in advanced renal cell carcinoma (RCC) by prospectively assigning ipilimumab/nivolumab or nivolumab/cabozantinib according to a patient’s ribonucleic acid sequence (RNAseq)-defined biologic cluster.

SECONDARY OBJECTIVE:

I. To assess clinical outcome of cluster-assigned treatment in front-line metastatic renal cell carcinoma (mRCC).

EXPLORATORY OBJECTIVE:

I. To assess tissue and peripheral blood for pharmacodynamic correlations with response to treatment.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I:

INDUCTION: Patients receive ipilimumab and nivolumab intravenously (IV) on day 1. Cycles repeat every 21 days for 4 cycles.

MAINTENANCE: Patients receive nivolumab IV on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV on day 1 and cabozantinib orally (PO) once a day (QD). Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days from last dose.