An Investigational Immunotherapy Study of NKTR-214 and Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - 17-214-08

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001423-40-FR

Enrollment

1020

Registered

2018-08-29

Start date

2018-10-25

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated unresectable or metastatic melanoma MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial - COMMERCIAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of /= 80% (minors ages 12-17 only) - Histologically confirmed stage III (unresectable) or stage IV melenoma - Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment Are the trial subjects under 18? yes Number of subjects for this age range: 51 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 561 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 408

Exclusion criteria

Exclusion criteria: - Active brain metastases or leptomeningeal metastases - Uveal melanoma - Participants with an active, known or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine whether an investigational immunotherapy NKTR-214, when combined with nivolumab, is more effective than nivolumab by itself in participants with unresectable or metastatic melanoma that is previously untreated;Secondary Objective: - To evaluate efficacy of NKTR-214 combined with nivolumab and that of nivolumab monotherapy - To evaluate the association between PD-L1 tumor expression on tumor cells (= 1% or < 1%/indeterminate) and efficacy measures including PFS and ORR by BICR and OS. -To evaluate the safety and tolerability of NKTR-214 combined with nivolumab and that of nivolumab monotherapy;Primary end point(s): - Overall response rate (ORR) by Blinded Independent central review (BICR) - Progression-free survival (PFS) by BICR - Overall survival (OS);Timepoint(s) of evaluation of this end point: Up to 5 years	—

Measure

Time frame

Main Objective: The purpose of this study is to determine whether an investigational immunotherapy NKTR-214, when combined with nivolumab, is more effective than nivolumab by itself in participants with unresectable or metastatic melanoma that is previously untreated;Secondary Objective: - To evaluate efficacy of NKTR-214 combined with nivolumab and that of nivolumab monotherapy - To evaluate the association between PD-L1 tumor expression on tumor cells (= 1% or < 1%/indeterminate) and efficacy measures including PFS and ORR by BICR and OS. -To evaluate the safety and tolerability of NKTR-214 combined with nivolumab and that of nivolumab monotherapy;Primary end point(s): - Overall response rate (ORR) by Blinded Independent central review (BICR) - Progression-free survival (PFS) by BICR - Overall survival (OS);Timepoint(s) of evaluation of this end point: Up to 5 years

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Secondary

Measure	Time frame
Secondary end point(s): - Clinical Benefit Rate (CBR) by BICR - Duration of Response (DoR) by BICR - Duration of overall Complete Response (DoCR) by BICR - Time To Response (TTR) by BICR - ORR by investigator - PFS by investigator - CBR by investigator - DoR by investigator - DoCR by investigator - TTR by investigator - PFS per BICR in biomarker population - ORR per BICR in biomarker population - OS in biomarker population - Incidence of Adverse Events (AEs) - Incidence of treatment-related AEs - Incidence of Serious Adverse Events (SAEs) - Incidence of treatment-related SAEs - Incidence of laboratory abnormalities ;Timepoint(s) of evaluation of this end point: Up to 5 years	—

Measure

Time frame

Secondary end point(s): - Clinical Benefit Rate (CBR) by BICR - Duration of Response (DoR) by BICR - Duration of overall Complete Response (DoCR) by BICR - Time To Response (TTR) by BICR - ORR by investigator - PFS by investigator - CBR by investigator - DoR by investigator - DoCR by investigator - TTR by investigator - PFS per BICR in biomarker population - ORR per BICR in biomarker population - OS in biomarker population - Incidence of Adverse Events (AEs) - Incidence of treatment-related AEs - Incidence of Serious Adverse Events (SAEs) - Incidence of treatment-related SAEs - Incidence of laboratory abnormalities ;Timepoint(s) of evaluation of this end point: Up to 5 years

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Countries

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

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026