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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 : October 17, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Biological: Bempegaldesleukin Drug: Sunitinib Biological: Nivolumab Drug: Cabozantinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
Patients in Arm A will receive Bempegaldesleukin in combination with Nivolumab.
Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
  • NKTR-214
  • BMS-986321

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936558

Active Comparator: Sunitinib or Cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
Drug: Sunitinib
Specified dose on specified days
Other Name: Sutent®

Drug: Cabozantinib
Specified dose on specified days
Other Name: Cabometyx®




Primary Outcome Measures :
  1. 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 ]
  2. ORR per RECIST 1.1 by BICR in IMDC all-risk patients [ Time Frame: Approximately 32 months ]
  3. Overall survival (OS) in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
  4. OS in IMDC all-risk patients [ Time Frame: 32-59 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) by BICR in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
  2. PFS by BICR in IMDC all risk-patients [ Time Frame: 32-59 months ]
  3. Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  4. ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 32-59 months ]
  5. PFS by investigator and in biomarker population [ Time Frame: 32-59 months ]
  6. OS in biomarker population [ Time Frame: 32-59 months ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729245


Contacts
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Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com

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Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
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Study Director: Bridget O'Keeffe Nektar Therapeutics

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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03729245     History of Changes
Other Study ID Numbers: 17-214-09
CA045002 ( Other Identifier: Bristol-Myers Squibb )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nektar Therapeutics:
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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Sunitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action