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Nektar 17-214-09: 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

Description

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).

Status

Accepting new patients

Primary Study Objective(s)

The objectives of this study are to determine:

  • Overall response rate (ORR)
  • Overall survival (OS)

Core eligibility

Note: This is only a partial list of eligibility criteria.

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Provide written, informed consent to participate in the study and follow the study procedures
  • Have a Karnofsky Performance Status (KPS) of at least 70
  • Have measurable disease per RECIST 1.1 criteria
  • Have a 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
  • Have 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
  • Have no prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC
  • Have archival tumor tissue available
  • Have stable brain metastases and meet other criteria

Excluding patients who:

  • Have an active, known or suspected autoimmune disease
  • Have a known additional malignancy that is progressing or requires active treatment
  • Have a tumor invading the superior vena cava (SVC) or other major blood vessels
  • Have a tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization