A Study of Bempegaldesleukin (NKTR-214: BEMPEG) 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 Carc

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab; Sunitinib

Criteria

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

• 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 for PD-L1 testing

• Adequate organ function without growth factor or transfusion support

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