MSB0010718C in Subjects With Skin Cancer

• Register: EUCTR
• Last refreshed on: 9 March 2015
• Main ID: EUCTR2014-000445-79-IT
• Date of registration: 24/09/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: MSB0010718C in Subjects With Skin Cancer
• Scientific title: A Phase II, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell carcinoma
• Date of first enrolment: 20/10/2014
• Target sample size: 84
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000445-79
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Australia, Austria, France, Germany, Italy, Japan, Spain, Switzerland, United States

Contacts

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion 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:
• 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Merkel Cell Carcinoma
MedDRA version: 17.0 Level: LLT Classification code 10064025 Term: Merkel cell carcinoma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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 name: Anti PD-L1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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.

Primary end point(s): The primary endpoint for the trial is the confirmed BOR, per RECIST 1.1, as determined by an IERC.

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

Timepoint(s) of evaluation of this end point: Tumor assessments will be performed every 6 weeks

Secondary Outcome(s)

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

Secondary ID(s)

EMR100070-003

Source(s) of Monetary Support

Merck KGaA