Recruiting Clinical Trials

A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma

By April 24, 2017 No Comments

Condition

To Determine Safety, Tolerability and Efficacy of ONCOS-102 in Combination With Chemotherapy

Estimated Enrollment: 30

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment

Study ID Numbers: ONCOS C719|2015-005143-13

Study First Received: July 13, 2016

Last Updated: February 9, 2017

Estimated Primary Completion Date: December 2018

 

Primary Outcome Measures:

Number of patients with any (Serious and Non-Serious) Adverse Event measured to assess safety and tolerability|To determine and compare tumour-specific immunological activation in the peripheral blood in the experimental group and the control group. Number of patients in the respective arms with induction of Tumor specific CD8+ T Cells in PBMC|To determine and compare immunological activation in tumour mass in the experimental group and the control Group. Number of patients in the respective arms with infiltration of CD8+ T Cells into tumours|To determine and compare overall response rate in the experimental group and the control group by number of patients with PD, SD, PR and CR in the respective arms|To determine and compare progression-free survival (PFS) in the experimental group and the control group by median time to progression in the respective arms|To determine and compare overall survival (OS) in the experimental group and the control group|To analyse immunological activation by comparing patients with and without presence of tumour antigen recognizing CD8+ T cells|To analyse clinical outcome by time to event endpoints (OS and PFS)

Sponsors and Collaborators:

Targovax Oy|Theradex|Targovax ASA

Website Link: https://ClinicalTrials.gov/show/NCT02879669

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