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Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
Window of Opportunity for Durvalumab (MEDI4736) Plus Metformin Trial of in Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

This pilot phase I trial studies how well durvalumab given with or without metformin works in treating participants with head and neck squamous cell carcinoma. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Metformin, a drug typically used for the treatment of diabetes, may help to reduce the metabolic activity of cancer cells and of surrounding supportive tissues. It is not yet known whether giving durvalumab with or without metformin may work better in treating participants with head and neck squamous carcinoma.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To investigate the combined effect of metformin and durvalumab on the immune tumor microenvironment, specifically with respect to alterations in T cell polarization (Th1/Th2 ratio) and tumor associated macrophage (TAM) (M1/M2 ratio) as measured by cytokine shifts in tumor specimens and peripheral blood. SECONDARY OBJECTIVES: I. To investigate the combined effect of metformin and durvalumab on the metabolic microenvironment, specifically with respect to alterations in immunohistochemical markers of the reverse Warburg effect. II. To further characterize the alterations in intratumoral immune cell populations (effector T cells [Teff], regulatory T cells [Tregs], tumor associated macrophages [TAMs], and myeloid-derived suppressor cells [MDSC]). III. To assess changes of the intratumoral immunophenotype and metabolism after exposure to durvalumab and metformin by transcriptome analysis using a ribonucleic acid-sequencing (RNA-seq) transcriptome analysis. IV. To assess the efficacy of combined durvalumab and metformin treatment prior to surgery as determined by radiographic response and immune-related response criteria (irRC). V. To assess the safety and tolerability of the combination of metformin and durvalumab. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03618654
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase Early Phase 1
Start date November 1, 2018
Completion date December 7, 2022
View Details
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