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

The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of NKTR-214 combined with nivolumab to that of a tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC).

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 RECIST 1.1 criteria
• Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with clear cell component including patients who may have sarcomatoid features
• At least one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic factors 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
• Patients with stable brain metastases may be enrolled if certain criteria are met
• Archival tumor tissue available

Exclusion Criteria:
• Patients who have an active, known or suspected autoimmune disease
• Patients who have a known additional malignancy that is progressing or requires active treatment
• Any tumor invading the superior vena cava (SVC) or other major blood vessels
• Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization
Phase III
Brendan Curti, M.D.
Nektar Therapeutics
  • Providence Cancer Institute Franz Clinic