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

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ClinicalTrials.gov Identifier: NCT03635983

Recruitment Status : Recruiting

First Posted : August 17, 2018

Last Update Posted : November 17, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Nektar Therapeutics

Information provided by (Responsible Party):

Bristol-Myers Squibb

Tracking Information

First Submitted Date ^ICMJE

August 16, 2018

First Posted Date ^ICMJE

August 17, 2018

Last Update Posted Date

November 17, 2020

Actual Study Start Date ^ICMJE

September 14, 2018

Estimated Primary Completion Date

April 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
Duration of response (DoR) [ Time Frame: Approximately 16 months ]
Time to response (TTR) [ Time Frame: Approximately 16 months ]
ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
OS in biomarker population [ Time Frame: Up to 59 months ]
Incidence of participants with non-serious Adverse Events (AEs) [ Time Frame: Up to 5 years ]
Incidence of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
Incidence of laboratory abnormalities in blood [ Time Frame: Up to 5 years ]
Incidence of laboratory abnormalities in blood serum [ Time Frame: Up to 5 years ]
Incidence of laboratory abnormalities in urine [ Time Frame: Up to 5 years ]

Original Secondary Outcome Measures ^ICMJE

Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
Duration of response (DoR) [ Time Frame: Approximately 16 months ]
Duration of overall complete response (DoCR) [ Time Frame: Approximately 16 months ]
Time to response (TTR) [ Time Frame: Approximately 16 months ]
ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
OS in biomarker population [ Time Frame: Up to 59 months ]
Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation [ Time Frame: Up to 5 years ]
Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: Combination
NKTR-214 + Nivolumab
Interventions:
- Biological: NKTR-214
- Biological: Nivolumab
Experimental: Monotherapy
Nivolumab

Intervention: Biological: Nivolumab

Publications *

Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

764

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

June 16, 2025

Estimated Primary Completion Date

April 25, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

12 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

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 #.

Listed Location Countries ^ICMJE

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03635983

Other Study ID Numbers ^ICMJE

CA045-001
2018-001423-40 ( EudraCT Number )
17-214-08 ( Other Identifier: Nektar Therapeutics )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Nektar Therapeutics

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

PRS Account

Bristol-Myers Squibb

Verification Date

November 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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