Clinical Trials Search
Clinical Trial 17938
Cancer Type: Cutaneous
Interventions:MSB00100718C (Avelumab); Not Applicable
Study Type: Treatment
Phase of Study: Phase II
A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of MSB0010718C in Subjects with Merkel Cell Carcinoma
The purpose of this study is to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC) who must have received one line of chemotherapy for the treatment of metastatic MCC.
Primary 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) by an Independent Endpoint Review Committee (IERC) in subjects with metastatic Merkel cells carcinoma after failing first-line chemotherapy. Secondary Objectives: Secondary objectives are as follows: To assess the duration of response according to RECIST 1.1 To assess the progression-free survival time (PFS) according to RECIST 1.1 To assess the safety profile of MSB0010718C in subjects with MCC To assess the overall survival (OS) time To assess response status according to RECIST 1.1 at 6 and 12 months after start of study treatment To characterize the population PK of MSB0010718C in subjects with MCC by sparse sampling To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure Exploratory Objectives: Exploratory objectives are as follows: To correlate the immunogenicity of MSB0010718C with clinical results (ORR and adverse events [AEs]) To assess the immune-related best overall response (irBOR) and immune-related PFS (irPFS) using the modified immune-related response criteria (irRC), derived from RECIST 1.1 To compare time to progression (TTP) on last prior anticancer therapy to PFS time on treatment with MSB0010718C. To evaluate changes in biomarkers in relation to disease responses to MSB0010718C. To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and best overall response (BOR) To explore the benefits of SB0010718C as perceived by subjects with metastatic MCC.