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A Study of NKTR-214 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 overall response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214) 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:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of NKTR-214 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
NKTR-214CD122-Biased Agonist, BMS-986321Combination of NKTR-214 + Nivolumab
SunitinibSutent®Sunitinib or Cabozantinib
NivolumabOpdivo®, BMS-936558Combination of NKTR-214 + Nivolumab
CabozantinibCabometyx®Sunitinib or Cabozantinib

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Combination of NKTR-214 + NivolumabExperimentalParticipants in Arm A will receive NKTR-214 in combination with Nivolumab.
  • NKTR-214
  • Nivolumab
Sunitinib or CabozantinibActive ComparatorParticipants in Arm B will receive the Investigator's choice of either one of two treatment options.
  • Sunitinib
  • Cabozantinib

Eligibility Criteria

        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

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
Time Frame:Approximately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS) by BICR
Time Frame:27-48 months
Safety Issue:
Description:
Measure:Incidence of treatment-related Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:ORR using RECIST 1.1 by investigator and in biomarker population
Time Frame:27-48 months
Safety Issue:
Description:
Measure:PFS by investigator and in biomarker population
Time Frame:27-48 months
Safety Issue:
Description:
Measure:OS in biomarker population
Time Frame:27-48 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:27-48 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status: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
  • Immunotherapy
  • NKTR-214
  • Nivolumab
  • Opdivo®
  • PD-L1

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