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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 : September 24, 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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Locations
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United States, Alaska
Investigator Site - Anchorage Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Investigator Site - Goodyear Recruiting
Goodyear, Arizona, United States, 85338
United States, Arkansas
Investigator Site - Little Rock Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Investigator Site - Duarte Recruiting
Duarte, California, United States, 91010
Investigator Site - Whittier Recruiting
Whittier, California, United States, 90603
United States, Georgia
Investigator Site - Atlanta Recruiting
Atlanta, Georgia, United States, 30322
United States, Maryland
Investigator Site - Baltimore Recruiting
Baltimore, Maryland, United States, 21201
United States, New York
Investigator Site - East Setauket Recruiting
East Setauket, New York, United States, 11733
Investigator Site - New York Recruiting
New York, New York, United States, 10029
United States, Ohio
Investigator Site - Kettering Recruiting
Kettering, Ohio, United States, 45429
United States, Oregon
Investigator Site - Portland Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Investigator Site - Allentown Recruiting
Allentown, Pennsylvania, United States, 18103
Investigator Site - Bethlehem Recruiting
Bethlehem, Pennsylvania, United States, 18015
Investigator Site - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Investigator Site - Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37401
United States, Texas
Investigator Site - Houston Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Investigator Site - Fairfax Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Investigator Site - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Argentina
Investigator Site - Pergamino Recruiting
Pergamino, Buenos Aires, Argentina, 2700
Investigator Site - Santa Rosa Recruiting
Santa Rosa, La Pampa, Argentina, 6300
Investigator Site - Viedma Recruiting
Viedma, Rio Negro, Argentina, R8500ACE
Investigator Site - Rosario Recruiting
Rosario, Santa Fe, Argentina, S2000DSV
Investigator Site - Rosario Recruiting
Rosario, Santa Fe, Argentina, S2002KDS
Investigator Site - Buenos Aires Not yet recruiting
Buenos Aires, Argentina, C1180AAX
Investigator Site - Buenos Aires Recruiting
Buenos Aires, Argentina, C1426ANZ
Investigator Site - Córdoba Recruiting
Córdoba, Argentina, X5000JHQ
Investigator Site - Córdoba Recruiting
Córdoba, Argentina, X5002AOQ
Investigator Site - Córdoba Recruiting
Córdoba, Argentina, X5008HHW
Investigator Site - La Rioja Recruiting
La Rioja, Argentina, F5300COE
Investigator Site - San Miguel De Tucumán Recruiting
San Miguel De Tucumán, Argentina, 4000
Australia, New South Wales
Investigator Site - Orange Recruiting
Orange, New South Wales, Australia, 2800
Investigator Site - Sydney Recruiting
Sydney, New South Wales, Australia, 2109
Australia, South Australia
Investigator Site - Kurralta Park Recruiting
Kurralta Park, South Australia, Australia, 5037
Australia, Western Australia
Investigator Site - Nedlands Recruiting
Nedlands, Western Australia, Australia, 6009
Brazil
Investigator Site - Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Chile
Investigator Site - Santiago Not yet recruiting
Santiago, Chile, 7500921
Investigator Site - Santiago Recruiting
Santiago, Chile, 7510032
Investigator Site - Santiago Recruiting
Santiago, Chile, 7520349
Investigator Site - Santiago Not yet recruiting
Santiago, Chile, 8420383
Investigator Site - Temuco Recruiting
Temuco, Chile, 4810371
Investigator Site - Viña Del Mar Recruiting
Viña Del Mar, Chile, 2520612
Investigator Site - Viña Del Mar Recruiting
Viña Del Mar, Chile, 2540364
China
Investigator Site - Beijing Not yet recruiting
Beijing, China, 100142
Colombia
Investigator Site - Bogotá Not yet recruiting
Bogotá, Colombia, 111321
Hong Kong
Investigator Site - Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Mexico
Investigator Site - Monterrey Not yet recruiting
Monterrey, Mexico, 64000
New Zealand
Investigator Site - Auckland Recruiting
Auckland, New Zealand, 1023
Investigator Site - Christchurch Not yet recruiting
Christchurch, New Zealand, 8011
Peru
Investigator Site - Trujillo Not yet recruiting
Trujillo, La LIbertad, Peru, 44
Investigator Site - Lima Not yet recruiting
Lima, Peru, 1
Investigator Site - Lima Not yet recruiting
Lima, Peru, 27
Investigator Site - Lima Not yet recruiting
Lima, Peru, 34
Investigator Site - Lima Not yet recruiting
Lima, Peru, Lima 13
Russian Federation
Investigator Site - Barnaul Not yet recruiting
Barnaul, Russian Federation, 656049
Investigator Site - Chelyabinsk Recruiting
Chelyabinsk, Russian Federation, 454087
Investigator Site - Kursk Not yet recruiting
Kursk, Russian Federation, 305035
Investigator Site - Moscow Recruiting
Moscow, Russian Federation, 121356
Investigator Site - Omsk Recruiting
Omsk, Russian Federation, 644013
Investigator Site - Pushkin Recruiting
Pushkin, Russian Federation, 196603
Investigator Site - Saint Petersburg Recruiting
Saint Petersburg, Russian Federation, 195271
Investigator Site - Saint Petersburg Recruiting
Saint Petersburg, Russian Federation, 199178
Investigator Site - Volzhskiy Recruiting
Volzhskiy, Russian Federation, 404120
Investigator Site - Yaroslavl Recruiting
Yaroslavl, Russian Federation, 150040
Singapore
Investigator Site - Singapore Not yet recruiting
Singapore, Singapore, 169610
Investigator Site - Singapore Recruiting
Singapore, Singapore, 258499
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: September 24, 2019
Last Verified: September 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