MSB0010718C in Subjects With Skin Cancer

Phase 1

• Conditions: Merkel Cell Carcinoma; MedDRA version: 17.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to assess the clinical activity of MSB0010718C as determined by the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with metastatic MCC after failing first-line chemotherapy.;Secondary Objective: Secondary objectives are as follows:<br>- To assess the duration of response <br>- To assess the progression-free survival time (PFS) <br>- To assess the safety profile of MSB0010718C in subjects with MCC<br>- To assess overall survival (OS) time;Primary end point(s): The primary endpoint for the trial is the confirmed BOR, per RECIST 1.1, as determined by an IERC.;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? Duration of response<br>? Progression-Free Survival (PFS) Time<br>? Safety<br>? Overall Survival (OS) Time;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed every 6 weeks