This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGChao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGUniversity Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGVanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGUniversity of Texas, Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGOverall response rate (ORR) (Arm 1)
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR = complete response (CR) + partial response (PR). The Agresti-Coull two-sided 95% confidence intervals (CIs) for the success rate will be reported.
Time frame: Up to 4 years
Overall response rate (Arm 2)
Assessed per RECIST 1.1. ORR = CR + PR. The Agresti-Coull two-sided 95% CIs for the success rate will be reported.
Time frame: Up to 4 years
Progression free survival
Possible risk factors will be compared for survival with Kaplan-Meier estimates and log-rank tests. The proportional hazards model will be used for adjusting tests of significance and estimating the hazard ratios. Will apply the generalized estimating equation (GEE) statistical procedure for longitudinal binary data analysis with multiple observable vectors for the same subject. For the continuous multiple time points or correlated data, will use the mixed effects model to conduct the profile analysis. The adjusted 95% CIs will be reported.
Time frame: Up to 4 years
Depth of response > 80%
Will apply the GEE statistical procedure for longitudinal binary data analysis with multiple observable vectors for the same subject. For the continuous multiple time points or correlated data, will use the mixed effects model to conduct the profile analysis. The adjusted 95% CIs will be reported.
Time frame: At 6 months
Incidence of immune-related adverse events
Adverse medical events will be tabulated. National Cancer Institute toxicity grade 3 and grade 4 laboratory abnormalities will be listed.
Time frame: Up to 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.