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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)

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ClinicalTrials.gov Identifier: NCT03729245
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE December 18, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk patients [ Time Frame: Approximately 32 months ]
  • ORR per RECIST 1.1 by BICR in IMDC all-risk patients [ Time Frame: Approximately 32 months ]
  • Overall survival (OS) in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
  • OS in IMDC all-risk patients [ Time Frame: 32-59 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • 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 ]
  • Overall survival (OS) [ Time Frame: 27-48 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Progression-free survival (PFS) by BICR in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
  • PFS by BICR in IMDC all risk-patients [ Time Frame: 32-59 months ]
  • Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 32-59 months ]
  • PFS by investigator and in biomarker population [ Time Frame: 32-59 months ]
  • OS in biomarker population [ Time Frame: 32-59 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Progression-free survival (PFS) by BICR [ Time Frame: 27-48 months ]
  • Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 27-48 months ]
  • PFS by investigator and in biomarker population [ Time Frame: 27-48 months ]
  • OS in biomarker population [ Time Frame: 27-48 months ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Biological: Bempegaldesleukin
    Specified dose on specified days
    Other Names:
    • NKTR-214
    • BMS-986321
  • Drug: Sunitinib
    Specified dose on specified days
    Other Name: Sutent®
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo®
    • BMS-936558
  • Drug: Cabozantinib
    Specified dose on specified days
    Other Name: Cabometyx®
Study Arms  ICMJE
  • Experimental: Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
    Patients in Arm A will receive Bempegaldesleukin in combination with Nivolumab.
    Interventions:
    • Biological: Bempegaldesleukin
    • Biological: Nivolumab
  • Active Comparator: Sunitinib or Cabozantinib
    Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
    Interventions:
    • Drug: Sunitinib
    • Drug: Cabozantinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)		 600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
  • Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score are eligible, whether favorable-, intermediate-, or poor-risk. 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

Key Exclusion Criteria:

  • Patients who have an active, known or suspected autoimmune disease (exceptions exist)
  • Patients who have a known additional malignancy that is progressing or requires active treatment
  • Any tumor invading the inferior or 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
  • Need for >2 antihypertensive classes of agents for management of hypertension (including diuretics)

Additional protocol defined inclusion/exclusion criteria and exceptions apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Chile,   China,   Colombia,   Hong Kong,   Mexico,   New Zealand,   Peru,   Russian Federation,   Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729245
Other Study ID Numbers  ICMJE 17-214-09
CA045002 ( Other Identifier: Bristol-Myers Squibb )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nektar Therapeutics
Study Sponsor  ICMJE Nektar Therapeutics
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Bridget O'Keeffe Nektar Therapeutics
PRS Account Nektar Therapeutics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP