Actively Recruiting
Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)
Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-04-27
54
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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 tumor's genetic makeup can improve treatment response. Participants are assigned to one of two treatment arms based on the tumor's 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.
CONDITIONS
Brief Title
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of renal cell carcinoma with a clear cell component
- Advanced or metastatic renal cell carcinoma not suitable for curative surgery or radiation
- Ability to understand and sign the informed consent form
- Male or female 18 years of age or older
- Karnofsky performance status of 70% or higher
- No prior systemic therapy for renal cell carcinoma in any setting
- At least one measurable lesion according to RECIST 1.1 criteria
- Availability of tumor tissue suitable for RNA sequencing (excluding bone metastasis tissue without soft tissue)
- Assigned to RNAseq cluster 1, 2, 4, or 5 (clusters 3, 6, 7 are excluded)
- Adequate kidney function with creatinine clearance 30 mL/min or higher
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal (except Gilbert's syndrome), ALT and AST ≤3 times upper limit of normal
- Women of childbearing potential must have a negative pregnancy test before treatment
You will not qualify if you...
- Major surgery requiring general anesthesia within 14 days before treatment
- Uncontrolled hypertension with blood pressure over 160/90 mmHg despite medication
- Active infection requiring intravenous treatment
- Preexisting gastrointestinal or non-gastrointestinal fistula
- Proteinuria greater than 2 g in 24 hours
- Non-healing wounds (for patients assigned to nivolumab plus cabozantinib)
- Clinically significant active bleeding including coughing up blood
- Inability to swallow oral medication or uncontrolled gastrointestinal disorders affecting drug absorption (for nivolumab plus cabozantinib patients)
- Significant cardiovascular disease including class III or IV heart failure, unstable angina within 3 months, or recent heart attack within 3 months
- Central nervous system metastases unless local therapy completed
- Use of systemic corticosteroids over 10 mg prednisone (or equivalent) daily or other immunosuppressive medications within 14 days before treatment
- Except for minimal systemic corticosteroids use such as topical or low-dose physiologic replacement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants receive assigned front-line therapy based on their RNA sequence-defined biologic cluster. Arm I includes 4 cycles of ipilimumab and nivolumab IV every 21 days followed by maintenance nivolumab IV every 4 weeks. Arm II includes nivolumab IV on day 1 and daily oral cabozantinib in 4-week cycles until disease progression or unacceptable toxicity.
Cycles repeat every 3 or 4 weeks depending on treatment phase
Duration - Within 30 days after treatment ends
Participants are followed up within 30 days after the last dose to assess outcomes and safety.
1 visit (in-person)
Trial Site Locations
Total: 6 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Service for Timely Access
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here