A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma

Date de début de l'étude : 18 décembre 2018

Key Inclusion Criteria: * Provide written, informed consent to participate in the study and follow the study procedures * Karnofsky Performance Status (KPS) of at least 70% * Measurable disease per mRECIST 1.1 criteria * Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC * Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma. * No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC Key Exclusion Criteria: * An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist) * Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist) * Any tumor invading the wall of a major blood vessels * Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization * Need for \>2 medications for management of hypertension (including diuretics) * History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization Additional protocol defined inclusion/exclusion criteria and exceptions apply