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

Launched by VANDERBILT-INGRAM CANCER CENTER · Apr 29, 2022

Keywords

ClinConnect Summary

The OPTIC RCC Study is a clinical trial that aims to find out if genetic testing of kidney cancer tumors can help doctors choose the best treatment for patients with advanced clear cell renal cell carcinoma (RCC) that has spread to other parts of the body. In this study, patients will be treated with one of two FDA-approved combinations: one involves two immunotherapy drugs delivered through an IV, which helps the immune system fight the cancer; the other combines one immunotherapy drug with an oral pill that targets the cancer's growth. By looking at the specific genetic makeup of a patient's tumor, researchers hope to better match the treatment to that individual's cancer, potentially leading to better outcomes.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of advanced or metastatic clear cell RCC. They should not have received any previous systemic treatment for their cancer and must have at least one measurable tumor. Patients will have regular evaluations during the trial to monitor their response to the treatment and ensure their overall health. This study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they meet the eligibility criteria and if this trial is a suitable option for them.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• * =\< 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)