Clinical Trial TitleA phase 3, randomized, open-label study of nivolumab combined with cabozantinib or nivolumab and ipilimumab combined with cabozantinib versus sunitinib in participants with previously untreated, advanced or metastatic renal cell carcinoma.
Clinical Trial Protocol Description:
Study for nivolumab with cabozantinib or nivolumab and ipilimumab combined with abozantinib for subjects with renal cell carcinoma and to collect additional data on treatment safety
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histological confirmation of renal cell carcinoma (RCC) with a clear-cell component, including participants who may also have sarcomatoid features.
- Have advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC.
- Have no prior systemic therapy for RCC with the following exception:
- One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
- Haev a Karnofsky Performance Status (KPS) greater or equal to 70%.
You will be excluded from the study if any of the following criteria apply to you:
- Have any active CNS metastases. Participants with treated, stable CNS metastases for at least 3 months are eligible as long as they meet the following criteria: Treated CNS metastases are defined as having no ongoing requirement for corticosteroids for at least 2 weeks prior to randomization and no evidence of progression or hemorrhage after treatment completed at least 3 months prior to randomization, as ascertained by clinical examination and brain imaging (MRI or CT). (Stable dose of anticonvulsants is allowed). Treatment for CNS metastases may include whole brain radiotherapy, radiosurgery (eg, RS, gamma knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to randomization are not eligible. Baseline imaging of the brain is required within 28 days prior to randomization.
- Have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Have any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Have had prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
This is a partial list of inclusion and exclusion criteria.