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New treatment option for Advanced Clear Cell Renal Cell Carcinoma
Official title Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
ClinicalTrials.gov ID: NCT05361720
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%
You likely can't join if
- =\< 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
See the full eligibility criteria
- 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
- =\< 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...
- 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
- people 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...
- In the absence of active autoimmune disease: people are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =\< 10 mg/day...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Orange, California, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Orange, California, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.