Merkel Cell Carcinoma MedDRA version: 17.0 Level: LLT Classification code 10064025 Term: Merkel cell carcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: anti PD-L1
Product Code: MSB0010718C
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: MSB0010718C
Other descriptive nam
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - To assess the duration of response - To assess the progression-free survival time (PFS) - To assess the safety profile of MSB0010718C in subjects with MCC - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of response • Progression-Free Survival (PFS) Time • Safety • Overall Survival (OS) Time ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed every 6 weeks | — |
Countries
Australia, Austria, France, Germany, Italy, Japan, Spain, Switzerland, United States
Contacts
Public ContactCommunication Centre Merck KGaA
Merck KGaA
Outcome results
None listed