NCT03302247

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Non Small Cell Lung Cancer Stage IIIB

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Monoclonal antibody against non small cell lung cancer
DRUG	Nivolumab+Gemcitabine	Gemcitabine is added to the Nivolumab treatment

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-03-21
• Completion: 2019-07-12
• First posted: 2017-10-05
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study