Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Nivolumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle

Monoclonal antibody against non small cell lung cancer

Gemcitabine is added to the Nivolumab treatment

Nivolumab+Gemcitabine

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.

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

Nivolumab 240mg, IV on day 1, 15 + Gemcitabine 1000mg/m2, IV on day 1, 8, 15 of 28 days cycle

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

Immunosuppression in terms of number of circulating MDSC in the blood by comparing within each arm reduction in the number of MDSCs after each cycle of treatment

Evaluate if MDSC elimination by gemcitabine results in increase in T-cell activity

Fox Chase Cancer Center

Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle

Nivolumab: Monoclonal antibody against non small cell lung cancer

Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Martin Edelman

The study has closed prematurely. Insufficient data for analysis

Decrease in Macrophage Derived Suppressor Cells (MDSC) Numbers as a Result of Treatment With Gemcitabine.

The study has closed prematurely. Data was not collected

Spots Global Cancer Trial Database for nivolumab+gemcitabine