Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination with Ipilimumab vs Ipilimumab alone in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Phase 1

Active, not recruiting

• Conditions: nresectable or metastatic Melanoma; MedDRA version: 14.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002018-11-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-05
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

-ECOG PS 0 or 1.
- Histologically confirmed unresectable Stage III or Stage IV Melanoma, as per AJCC staging system
- No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized.
- Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses. In order to be treated, tumor tissue should be received by the central laboratory. In the event that lab kits are not available on-site when a subject meets all other criteria to begin treatment, the subject may begin treatment prior to tissue having been received by the central lab. In such cases, tissue should be sent to the central lab as soon as kits become available.
-Known BRAF V600 mutation status. Subjects with either V600 wild-type or V600 mutation-melanoma are eligible.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
-Ocular melanoma
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary purpose of this study is to compare the objective response rate (ORR), as determined by investigators, of nivolumab combined with ipilimumab versus ipilimumab monotherapy in subjects with unresectable or metastatic melanoma.;Secondary Objective: - Investigator-assessed progression-free survival in BRAF WT subjects<br>- Investigator-assessed objective response rate and progression-free survival in BRAF mutant subjects<br>- Changes from baseline in the EORTC QLQ-C30 global health status/QoL composite scale.;Primary end point(s): The primary endpoint of this study is objective response rate (ORR) as determined by investigators in BRAF WT subjects;Timepoint(s) of evaluation of this end point: Baseline, Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Investigator-assessed progression-free survival in BRAF WT subjects<br>- Investigator-assessed objective response rate and progression-free survival in BRAF mutant subjects<br>- Changes from baseline in the EORTC QLQ-C30 global health status/QoL composite scale.;Timepoint(s) of evaluation of this end point: -Baseline, Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years)<br>-Baseline, Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years)<br>-Baseline, every 6 weeks for the first 6 months.