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Genetic Testing for Advanced Kidney Cancer Treatment (OPTIC RCC Study)

This study is testing if genetic testing of your tumor can help doctors choose the best treatment for advanced or metastatic (spread to other parts of the body) clear cell kidney cancer. The study compares two common treatment approaches: one uses two immunotherapy drugs, nivolumab and ipilimumab, given through an IV. The other uses nivolumab (IV) combined with cabozantinib, an oral pill. The goal is to see if matching your genetic information to one of these treatments leads to a better response. You may be able to join if you are 18 or older, have clear cell kidney cancer that has spread, and meet other health criteria. The study will measure how many people respond to the treatment over up to four years. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 54 participants. It assigns participants to one of two treatment arms based on genetic testing.
What's involved
Participants will receive either nivolumab and ipilimumab intravenously, or nivolumab intravenously and cabozantinib orally. Treatment cycles repeat every 21 days or 4 weeks, depending on the arm.
Compensation
Not stated in the trial record.
Follow-up
After completing study treatment, participants are followed up within 30 days from the last dose. Overall response rate will be measured for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05361720

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Vanderbilt-Ingram Cancer Center
~54 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CabozantinibIpilimumabNivolumab

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR) (Arm 1)
Measured over Up to 4 years
+1 more outcome measured

Conditions

Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8

Explore related trials

Clear Cell Renal Cell CarcinomaRNA-sequencing cluster

NCT05361720

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Chao Family Comprehensive Cancer Center

    Orange, Californiastudy coordinator listed

    Recruiting

  • City of Hope National Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • University of Texas, Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brian I Rini, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Email the study team

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Eligibility criteria

Inclusion

Histological confirmation of RCC with a clear cell component
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \[AJCC\] stage IV) RCC
Patient can comprehend and sign the study informed consent form
Male or female \>= 18 years of age at the time of informed consent
Karnofsky performance status (KPS) of \>= 70%
No prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting
At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tumor tissue for ribonucleic acid (RNA)-sequencing (tumor tissue from bony metastasis is not suitable but a soft tissue component around bone is acceptable)
Screening tissue consent- Patient must be assigned to either Cluster 1/2 or 4/5. Patients assigned to cluster 3/6/7 will not be eligible for the treatment study
Adequate renal function defined as calculated creatinine clearance \>= 30 mL/min per the Cockcroft and Gault formula
Adequate liver function defined by:
Total bilirubin =\< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment
Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal
Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes

Exclusion

=\< 14 days before first dose of protocol-indicated treatment:
Major surgery requiring general anesthesia
Inadequately controlled hypertension (systolic blood pressure \[SBP\] \> 160/90 mmHg)
Anti-hypertensive medications are permitted.
Active infection requiring infusional treatment
Has preexisting gastrointestinal or non-gastrointestinal fistula
Proteinuria \> 2 g/ 24 hours (hrs)
If patient has 1+ protein on urine dipstick then a 24 hr urine collection is required
Non-healing wounds on any part of the body (for patients assigned to Cabo/Nivo only)
Known clinically significant active bleeding including hemoptysis
Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug (for patients assigned to Cabo/Nivo only) - e.g., Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \> 4 loose stools per day), malabsorption, or bowel obstruction
Significant cardiovascular disease or condition including:
Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) functional criteria
Unstable angina pectoris (i.e., last episode =\< 3 months prior to first dose of protocol-indicated treatment)
Myocardial infarction within 3 months prior to starting treatment
Subjects with central nervous system (CNS) metastases are eligible after they have completed local therapy (e.g., whole brain radiation therapy \[WBRT\], surgery or radiosurgery)
Any condition requiring systemic treatment with either systemic corticosteroids (\> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment
In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =\< 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids =\< 10 mg/day prednisone or equivalent daily (e.g., hormone replacement therapy needed in patients with hypophysitis)

What this trial measures

  • Overall response rate (ORR) (Arm 1)Up to 4 years

    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.

  • Overall response rate (Arm 2)Up to 4 years

    Assessed per RECIST 1.1. ORR = CR + PR. The Agresti-Coull two-sided 95% CIs for the success rate will be reported.