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)

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 7, 2022

Interventions

  • Biological: bempegaldesleukin
    • Specified dose on specified days
  • Drug: sunitinib
    • Specified dose on specified days
  • Biological: nivolumab
    • Specified dose on specified days
  • Drug: cabozantinib
    • Specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Combination of bempegaldesleukin + nivolumab
    • Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
  • Active Comparator: sunitinib or cabozantinib
    • Patients in Arm B will receive the Investigator’s choice of either one of two treatment options.

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
    • Time Frame: Approximately 32 months
    • ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
  • Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
    • Time Frame: Approximately 32 months
    • OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.

Secondary Measures

  • Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
    • Time Frame: Approximately 32 months
    • Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nektar Therapeutics
  • Collaborator
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Nektar Therapeutics

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