NCT03618654

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Oral Cavity Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Metformin	Given PO
BIOLOGICAL	Durvalumab	Given IV

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-11-20
• Completion: 2022-12-07
• First posted: 2018-08-07
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study