Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy

Non Small Cell Lung Cancer Stage IIIB Clinical Trial

Official title: Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy

Status Terminated

Clinical Trial Summary

Metastatic non small cell lung cancer can be treated with cytotoxic chemotherapy or using recently approved immunotherapy with antibody, Nivolumab. Both the therapies have limitation due to development of tolerance or immunosuppression. This trial combines one drug from each category, immunotherapeutic Nivolumab and chemotherapeutic gemcitabine as it was reported that gemcitabine reduces immunosuppression by killing myeloid derived suppressor cells, thereby increasing the efficacy of Nivolumab.

Clinical Trial Description

Primary Objective

• The primary objective of this proposal is to evaluate gemcitabine as a method of MDSC depletion.

Secondary Objectives

• Evaluate whether these measures result in enhanced T-cell activity and/or NK cell function and number.

• Determine the tolerability and clinical activity (including response rate and survival) of this approach.

• Correlate MDSC number with tumor PD-L1 expression ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer Stage IIIB

• NCT number: NCT03302247
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: January 15, 2018
• Completion date: July 12, 2019