An Investigational Immuno-therapy Study of BMS-986205 Combined with Nivolumab, Compared to Nivolumab by itself, in Patients with Advanced Melanoma

A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with Nivolumab versus Nivolumab in Participants with Metastatic or Unresectable Melanoma that is Previously Untreated

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002499-14-DE

Enrollment

933

Registered

2017-10-19

Start date

2018-03-01

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

Metastatic or Unresectable Melanoma that is Previously Untreated 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-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Per Revised Protocol 01, enrollment in the current study has been stopped as of 19-Apr-2018 - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 - Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) - Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) - Measurable disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 634 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 271

Exclusion criteria

Exclusion criteria: Per Revised Protocol 01, enrollment in the current study has been stopped as of 19-Apr-2018 - Active brain metastases or leptomeningeal metastases - Uveal or ocular melanoma - Participants with active, known, or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Design outcomes

Primary

Measure	Time frame
Primary end point(s): enrollment in this study was closed and only safety assessments will be collected. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker specimens may be analyzed, but no formal analyses are planned;Timepoint(s) of evaluation of this end point: Not applicable as per Revprot01;Main Objective: Not applicable per Revised Protocol 01. Only safety assessments will be conducted. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker samples may be analyzed, but no further collections are planned with this revised protocol.;Secondary Objective: Not applicable per Revised Protocol 01. Only safety assessments will be conducted. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker samples may be analyzed, but no further collections are planned with this revised protocol.	—

Measure

Time frame

Primary end point(s): enrollment in this study was closed and only safety assessments will be collected. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker specimens may be analyzed, but no formal analyses are planned;Timepoint(s) of evaluation of this end point: Not applicable as per Revprot01;Main Objective: Not applicable per Revised Protocol 01. Only safety assessments will be conducted. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker samples may be analyzed, but no further collections are planned with this revised protocol.;Secondary Objective: Not applicable per Revised Protocol 01. Only safety assessments will be conducted. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker samples may be analyzed, but no further collections are planned with this revised protocol.

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Secondary

Measure	Time frame
Secondary end point(s): enrollment in this study was closed and only safety assessments will be collected. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker specimens may be analyzed, but no formal analyses are planned;Timepoint(s) of evaluation of this end point: Not applicable as per Revprot01	—

Measure

Time frame

Secondary end point(s): enrollment in this study was closed and only safety assessments will be collected. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource utilization, are planned. Previously collected biomarker specimens may be analyzed, but no formal analyses are planned;Timepoint(s) of evaluation of this end point: Not applicable as per Revprot01

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Countries

Australia, Brazil, Canada, Chile, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, 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