Condition
Solid Tumors
Estimated Enrollment: 1706
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: EMR 100070-001|2013-002834-19
Study First Received: January 14, 2013
Last Updated: December 22, 2016
Estimated Primary Completion Date: May 2018
Primary Outcome Measures:
Dose Limiting Toxicity|Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) for Efficacy Expansion Cohorts|Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0|Pharmacokinetic parameters: AUC (0-t), AUC (0-infinity), λz, Cmax, Tmax, T(1/2) of avelumab|Immune-related Best Overall Response (irBOR) and Best Overall Response (BOR) according to modified Immune-related response criteria (irRC) and RECIST version 1.1, respectively|Immune-related Progression-Free Survival (irPFS) time and Progression-Free Survival (PFS) Time according to modified irRC and RECIST version 1.1 , respectively|Overall Survival Time|Pharmacodynamic profile of avelumab to include serum levels of cytokines|Number of subjects with anti-avelumab antibodies|Level of PD-L1 tumor expression|Unconfirmed response according to RECIST 1.1 per investigator assessment for Primary expansion cohort|Duration of response according to modified irRC and RECIST 1.1 per investigator assessment|Progression Free Survival time according to RECIST 1.1 for Efficacy Expansion Cohorts|Duration of response according to RECIST 1.1 for Efficacy Expansion cohorts|Confirmed BOR as per RECIST 1.1 as adjudicated by an Independent Endpoint Review Committee (IERC) for secondary urothelial carcinoma cohort
Sponsors and Collaborators:
EMD Serono|Merck KGaA
Website Link: https://ClinicalTrials.gov/show/NCT01772004
