Working… Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03729245
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : July 30, 2021
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Biological: bempegaldesleukin Drug: sunitinib Biological: nivolumab Drug: cabozantinib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 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 + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
Biological: bempegaldesleukin
Specified dose on specified days
Other Names:
  • 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. ORR using mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients [ Time Frame: Approximately 32 months ]
    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

  2. ORR per mRECIST 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) per mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
  2. PFS per mRECIST 1.1 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 per mRECIST 1.1 by BICR in biomarker population [ Time Frame: 32-59 months ]
  5. PFS per mRECIST 1.1 by BICR 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT03729245

Show Show 116 study locations
Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Layout table for investigator information
Study Director: Study Director Nektar Therapeutics
Layout table for additonal information
Responsible Party: Nektar Therapeutics Identifier: NCT03729245    
Other Study ID Numbers: 17-214-09
CA045002 ( Other Identifier: Bristol-Myers Squibb Protocol ID )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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-Biased Agonist
CD122-Biased Cytokine
IL-2 receptor agonist
Immuno-oncology therapy
IL-2 pathway agonist
Checkpoint inhibition
Immune checkpoint inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
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