A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell … (NCT03635892) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma
United States60 participantsStarted 2018-08-13
Plain-language summary
The purpose of this study is to compare any good and bad effects of using a combination of nivolumab (Opdivo®) and cabozantinib (Cabometyx®) in people with metastatic kidney cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed and dated IRB-approved Informed Consent Form
* Pathologic or histologically confirmed unresectable advanced or metastatic nccRCC
* 0 or 1 prior systemic therapies, including treatment in the adjuvant setting
* Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion.
* Measurable disease, as defined by RECIST 1.1
* Age ≥18 years
* KPS ≥ 70
* Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless adverse events (AE(s)) are clinically nonsignificant and/or stable on supportive therapy.
* Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
* ANC ≥ 1500 cells/μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
* WBC counts ≥ 2500/μL and ≤ 15,000/μL without G-CSF
* Lymphocyte count ≥ 500/μL
* Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
* Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal …