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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)

NCT03729245

Description:

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).

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 17-214-09
  • SECONDARY ID: CA045002
  • NCT ID: NCT03729245

Conditions

  • Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma

Interventions

DrugSynonymsArms
bempegaldesleukinBEMPEG, BMS-986321Combination of bempegaldesleukin + nivolumab
sunitinibSutent®sunitinib or cabozantinib
nivolumabOpdivo®, BMS-936558Combination of bempegaldesleukin + nivolumab
cabozantinibCabometyx®sunitinib or cabozantinib

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Combination of bempegaldesleukin + nivolumabExperimentalPatients in Arm A will receive bempegaldesleukin in combination with nivolumab.
  • bempegaldesleukin
  • nivolumab
sunitinib or cabozantinibActive ComparatorPatients in Arm B will receive the Investigator's choice of either one of two treatment options.
  • sunitinib
  • cabozantinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR using mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients
Time Frame:Approximately 32 months
Safety Issue:
Description:Objective response rate (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) intermediate- or poor-risk patients

Secondary Outcome Measures

Measure:Progression-free survival (PFS) per mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients
Time Frame:32-59 months
Safety Issue:
Description:
Measure:PFS per mRECIST 1.1 by BICR in IMDC all risk-patients
Time Frame:32-59 months
Safety Issue:
Description:
Measure:Incidence of treatment-related Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:ORR per mRECIST 1.1 by BICR in biomarker population
Time Frame:32-59 months
Safety Issue:
Description:
Measure:PFS per mRECIST 1.1 by BICR in biomarker population
Time Frame:32-59 months
Safety Issue:
Description:
Measure:OS in biomarker population
Time Frame:32-59 months
Safety Issue:
Description:
Measure:Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19)
Time Frame:32-59 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Nektar Therapeutics

Trial Keywords

  • Kidney Cancer
  • Kidney Neoplasms
  • Renal Cancer
  • Renal Neoplasms
  • CD122
  • CD122-Biased Agonist
  • CD122-Biased Cytokine
  • IL-2 receptor agonist
  • Immuno-oncology therapy
  • NKTR-214
  • Nivolumab
  • Opdivo®
  • PD-L1
  • PD-1
  • Bempegaldesleukin
  • IL-2
  • BEMPEG
  • CD122-Preferential
  • IL-2 pathway agonist
  • Checkpoint inhibition
  • Immune checkpoint inhibitor

Last Updated

August 26, 2021