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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 : May 10, 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 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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Biological: NKTR-214 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 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Combination of NKTR-214 + Nivolumab
Participants in Arm A will receive NKTR-214 in combination with Nivolumab.
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • CD122-Biased Agonist
  • BMS-986321

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

Active Comparator: Sunitinib or Cabozantinib
Participants 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) [ Time Frame: Approximately 2 years ]
  2. Overall survival (OS) [ Time Frame: 27-48 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) by BICR [ Time Frame: 27-48 months ]
  2. Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  3. ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 27-48 months ]
  4. PFS by investigator and in biomarker population [ Time Frame: 27-48 months ]
  5. OS in biomarker population [ Time Frame: 27-48 months ]
  6. 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 ]


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

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


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

  Show 19 Study Locations
Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
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Study Director: Alison Hannah 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: May 10, 2019
Last Verified: May 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
Immunotherapy
NKTR-214
Nivolumab
Opdivo®
PD-L1

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