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
