Nektar 17-214-09 / BMS CA045002 Advanced Renal Cell Cancer

Full Name

17-214-09/CA045002:  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).

Eligibility

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
Doctor(s) Running This Study

Accepting New Patients

Specialties
Hematology/Medical Oncology
Area of focus
Melanoma
Kidney cancer (renal cancer)
Sarcoma
LVHN Affiliates
Lehigh Valley Cancer Institute
Locations

1240 S Cedar Crest Blvd
Suite 401
Allentown, PA 18103-6218
United States

181 East Brown Street
East Stroudsburg, PA 18301-3004
United States

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