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
Last Update Posted : June 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: NKTR-214 Biological: Nivolumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 783 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 21, 2018 |
Actual Primary Completion Date : | November 19, 2021 |
Estimated Study Completion Date : | February 28, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination
NKTR-214 + Nivolumab
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Biological: NKTR-214
Specified dose on specified days
Other Names:
Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Monotherapy
Nivolumab
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Biological: Nivolumab
Specified dose on specified days
Other Names:
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- 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 ]
- 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 ]

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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 |
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 apply

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

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 Posted: | August 17, 2018 Key Record Dates |
Last Update Posted: | June 23, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NKTR-214 Nivolumab Immunotherapy bempegaldesleukin (BEMPEG: NKTR-214) |
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 Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |