Study to compare the effect of ipilimumab retreatment with chemotherapy in advanced melanoma

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

• Registration Number: EUCTR2012-003291-38-AT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-06
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Histological diagnosis of unresectable stage III or IV metastatic melanoma
• Prior ipilimumab induction treatment (3mg/kg)
• Documented disease control (SD = 3 months or PR/CR) after ipilimumab Induction
• Documented progressive disease following disease control

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 52

Exclusion Criteria

• Subjects with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab.
• Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
• Subjects who experienced any grade 3 irAE (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab.
• Subjects with a prior irAE that has not improved to grade 1 or better atrandomization.

Study & Design

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