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A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635983
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Condition or disease Intervention/treatment Phase
Melanoma Biological: NKTR-214 Biological: Nivolumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : April 25, 2022
Estimated Study Completion Date : June 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination
NKTR-214 + Nivolumab
 Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin
  • BMS-986321

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 16 months ]
  2. Progression-free survival (PFS) by BICR [ Time Frame: Approximately 22 months ]
  3. Overall survival (OS) [ Time Frame: Up to 59 months ]

Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
  2. Duration of response (DoR) [ Time Frame: Approximately 16 months ]
  3. Time to response (TTR) [ Time Frame: Approximately 16 months ]
  4. ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
  5. PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
  6. OS in biomarker population [ Time Frame: Up to 59 months ]
  7. Incidence of participants with non-serious Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  8. Incidence of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  9. Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
  10. Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
  11. Incidence of laboratory abnormalities in blood [ Time Frame: Up to 5 years ]
  12. Incidence of laboratory abnormalities in blood serum [ Time Frame: Up to 5 years ]
  13. Incidence of laboratory abnormalities in urine [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Uveal melanoma
  • Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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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): NCT03635983


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03635983    
Other Study ID Numbers: CA045-001
2018-001423-40 ( EudraCT Number )
17-214-08 ( Other Identifier: Nektar Therapeutics )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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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 Bristol-Myers Squibb:
NKTR-214
Nivolumab
Immunotherapy
bempegaldesleukin (BEMPEG: NKTR-214)
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents