A study to compare BMS-936558 to the physician’s choice of either dacarbazine or carboplatin and paclitaxel in advanced melanoma patients that have progressed following anti-CTLA-4 therapy

A Randomized Open-Label Phase III Trial of BMS-936558 versus Investigator’s Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy Pharmacogenetics Blood Sample Amendment 01- dated 07-aug-12, version 1.0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001828-35-BE

Enrollment

520

Registered

2012-11-05

Start date

2013-02-15

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

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

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) men & women = 18 years of age 2) ECOG PS 0-1 3) Histologically confirmed Stage III (unresectable)/Stage IV melanoma 4) Measurable disease by CT/MRI per RECIST 1.1 criteria 5) Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens 6) Pre-treatment fresh core, excision or punch biopsy. 7) Archival FFPE tumor material if available. 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 364 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 156

Exclusion criteria

Exclusion criteria: 1) Any treatment in a BMS-936558 trial. 2) Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg QD prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration. 3) Active, known or suspected autoimmune disease 4) Unknown BRAF status 5) Active brain metastasis or leptomeningeal metastasis. 6) Ocular melanoma 7) Prior therapy with anti-PD-1, anti-PD-L1 or anti-PD-L2.

Design outcomes

Primary

Measure	Time frame
Main Objective: To estimate the ORR in BMS-936558 (nivolumab) treatment group and to compare OS of BMS-936558 (nivolumab) to investigator's choice in subjects with advanced melanoma;Secondary Objective: 1. Progression-free survival (PFS) 2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS. 3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30 ;Primary end point(s): To estimate the ORR in BMS-936558 (nivolumab) treatment group and to compare OS of BMS-936558 (nivolumab) to investigator's choice in subjects with advanced melanoma;Timepoint(s) of evaluation of this end point: ORR (Time frame 18 months) ORR is defined as the number of subjects with a Best Overall Response (BOR) of CR or PR divided by the number of randomized subjects. OS (Timeframe: 23 months) Overall Survival is defined as the time from randomization to the date of death.	—

Measure

Time frame

Main Objective: To estimate the ORR in BMS-936558 (nivolumab) treatment group and to compare OS of BMS-936558 (nivolumab) to investigator's choice in subjects with advanced melanoma;Secondary Objective: 1. Progression-free survival (PFS) 2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS. 3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30 ;Primary end point(s): To estimate the ORR in BMS-936558 (nivolumab) treatment group and to compare OS of BMS-936558 (nivolumab) to investigator's choice in subjects with advanced melanoma;Timepoint(s) of evaluation of this end point: ORR (Time frame 18 months) ORR is defined as the number of subjects with a Best Overall Response (BOR) of CR or PR divided by the number of randomized subjects. OS (Timeframe: 23 months) Overall Survival is defined as the time from randomization to the date of death.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Progression-free survival (PFS) 2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS. 3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30 ;Timepoint(s) of evaluation of this end point: 1. Timeframe: 23 Months 2. Timeframe: 23 Months 3. Timeframe: 23 Months	—

Measure

Time frame

Secondary end point(s): 1. Progression-free survival (PFS) 2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS. 3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30 ;Timepoint(s) of evaluation of this end point: 1. Timeframe: 23 Months 2. Timeframe: 23 Months 3. Timeframe: 23 Months

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Countries

Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

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