Status:
RECRUITING
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
United States Department of Defense
Conditions:
Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed 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 accordi...
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)
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05361720
Start Date
December 1 2022
End Date
July 1 2026
Last Update
July 23 2025
Active Locations (6)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
3
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195