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 Carcinoma (RCC)

Nektar Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Metastatic Renal Cell Carcinoma; Renal Cell Carcinoma

Treatments: Biological: nivolumab; Drug: sunitinib; Biological: bempegaldesleukin; Drug: cabozantinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03729245

17-214-09

CA045002 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 623 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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623 participants in 2 patient groups

Combination of bempegaldesleukin + nivolumab

Experimental group

Description:

Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.

Treatment:

Biological: bempegaldesleukin

Biological: nivolumab

sunitinib or cabozantinib

Active Comparator group

Description:

Patients in Arm B will receive the Investigator's choice of either one of two treatment options.

Treatment:

Drug: cabozantinib

Drug: sunitinib