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

Phase 1

• Conditions: nresectable or metastatic melanoma; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001828-35-DK
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-08
• Study Completion: 2020-12-29
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;Secondary Objective: 1. Progression-free survival (PFS) <br>2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS.<br>3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30 <br>;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<br>;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. <br><br>OS (Timeframe: 23 months) Overall Survival is defined as the time from randomization to the date of death.<br>

Secondary Outcome Measures

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