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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

Top West Virginia Mesothelioma Lawyer | Law Firm | Attorney | GPW > 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

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

Estimated reading time: 1 min

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

Estimated Enrollment: 31

Gender: All

Min Age: 18 Years

Age Group: Adult, Older Adult

Current Status: Active, not recruiting

Study Results: No Results Available

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

Interventions: ONCOS-102, Pemetrexed/cisplatin (carboplatin)

Phase:

Study Type: Interventional

Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label),Primary Purpose: Treatment

Primary Completion Date: June 2020

Completion Date:

Last  Posted Date: May 29, 2019

Location: Centre Georges-François Leclerc, Dijon, France

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

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