Last updated on February 2020

A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malignant Adenoma | Metastatic Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma | Adenocarcinoma | Kidney Cancer | Malignant neoplasm of kidney | Renal Cell Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 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
  • Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score are eligible, whether favorable-, intermediate-, or poor-risk. 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
  • Patients with stable brain metastases following local treatment may be enrolled if certain criteria are met
  • Tumor tissue (archival or fresh biopsy) identified and available

Key Exclusion Criteria:

  • Patients who have an active, known or suspected autoimmune disease (exceptions exist)
  • Patients who have a known additional malignancy that is progressing or requires active treatment
  • Any tumor invading the inferior or 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
  • Need for >2 antihypertensive classes of agents for management of hypertension (including diuretics)

Additional protocol defined inclusion/exclusion criteria and exceptions apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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