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 :
Active, not recruiting
First Posted : August 17, 2018
Results First Posted : December 19, 2022
Last Update Posted : March 15, 2023
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Melanoma |
Interventions |
Biological: NKTR-214 Biological: Nivolumab |
Enrollment | 783 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Bempegaldesleukin + Nivolumab | Nivolumab |
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Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks | Nivolumab 360 mg IV every 3 weeks |
Period Title: Pre-Treatment Period | ||
Started [1] | 391 | 392 |
Completed [2] | 387 | 382 |
Not Completed | 4 | 10 |
Reason Not Completed | ||
Not yet treated at the time of database lock | 1 | 0 |
Withdrawal by Subject | 0 | 7 |
Participant no longer meets study criteria | 1 | 0 |
Other reasons | 1 | 2 |
Disease Progression | 0 | 1 |
Adverse Event unrelated to Study drug | 1 | 0 |
[1]
Started=randomized
[2]
Completed=treated
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Period Title: Treatment Period | ||
Started [1] | 387 | 382 |
Completed [2] | 135 | 135 |
Not Completed | 252 | 247 |
Reason Not Completed | ||
Completed treatment period | 13 | 20 |
Participant request to discontinue Study treatment | 5 | 5 |
Withdrawal by Subject | 2 | 4 |
Death | 3 | 4 |
Poor/Non-compliance | 1 | 0 |
Participant no longer meets Study criteria | 0 | 2 |
Other reasons | 5 | 2 |
Disease progression | 184 | 168 |
Study drug toxicity | 26 | 29 |
Adverse event unrelated to Study drug | 10 | 11 |
Maximum clinical benefit | 3 | 2 |
[1]
Started=treated
[2]
Completed=on-going treatment
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Baseline Characteristics
Arm/Group Title | Bempegaldesleukin + Nivolumab | Nivolumab | Total | |
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Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks | Nivolumab 360 mg IV every 3 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 391 | 392 | 783 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 391 participants | 392 participants | 783 participants | |
61.3 (13.2) | 60.4 (13.5) | 60.8 (13.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 391 participants | 392 participants | 783 participants | |
Female |
162 41.4%
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163 41.6%
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325 41.5%
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Male |
229 58.6%
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229 58.4%
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458 58.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 391 participants | 392 participants | 783 participants | |
Hispanic or Latino |
81 20.7%
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73 18.6%
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154 19.7%
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Not Hispanic or Latino |
165 42.2%
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153 39.0%
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318 40.6%
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Unknown or Not Reported |
145 37.1%
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166 42.3%
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311 39.7%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 391 participants | 392 participants | 783 participants |
White | 379 | 379 | 758 | |
Black or African American | 2 | 4 | 6 | |
Asian | 1 | 0 | 1 | |
American Indian or Alaska Native | 5 | 2 | 7 | |
Other | 4 | 7 | 11 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
Phone: | Please Email |
EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Submitted: | August 16, 2018 |
First Posted: | August 17, 2018 |
Results First Submitted: | November 18, 2022 |
Results First Posted: | December 19, 2022 |
Last Update Posted: | March 15, 2023 |