MSB0010718C in Subjects With Skin Cancer

• Conditions: Merkel Cell Carcinoma; MedDRA version: 17.0Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000445-79-IT
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-24
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Signed written informed consent
• Age 18 years and above
• Histologically proven MCC as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate hematological, hepatic and renal function

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

• Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-programmed death 1 (PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody
• Subjects with active central nervous system (CNS) metastases are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy
• Previous malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
• Significant acute or chronic infections (among others, positive test for human immunodeficiency virus [HIV] 1/2) or known acquired immunodeficiency syndrome or with active or history of any hepatitis)
• Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE Version 4.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)

Study & Design

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