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

Conditions

• Non Small Cell Lung Cancer Stage IIIB

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Monoclonal antibody against non small cell lung cancer
• Nivolumab+Gemcitabine — DRUG
  Gemcitabine is added to the Nivolumab treatment

Study Details

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.

Key Dates

Start date

Jan 15, 2018

Status verified

Oct 2020

Primary completion

Mar 21, 2019

Completion

Jul 12, 2019

Study Design

Enrollment

3 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab+Gemcitabine
  Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle

Primary Outcome Measure

Decrease in Macrophage Derived Suppressor Cells (MDSC) Numbers as a Result of Treatment With Gemcitabine. [ Time Frame: 2 years ]

Locations (1)

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