EMR 100070-003: A Phase 2, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell carcinoma

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EMR 100070-003: A Phase 2, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell carcinoma

The primary objective of the trial is to assess the clinical activity of MSB0010718C in subjects with metastatic Merkel cell carcinoma (MCC) 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).

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

Exploratory objectives are as follows:
To characterize the pharmacokinetic (PK) profile of MSB0010718C
To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure and biological activity
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 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)

Protocol Number091401
Principal InvestigatorHoward Kaufman
PhasePhase II
ScopeNational
Applicable Disease SitesMelanoma, skin
Other Skin
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedMSB0010718C
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.