NCT03522584

Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Durvalumab (MEDI4736), Tremelimumab and Palliative Hypofractionated Image Guided Radiation Therapy (HIGRT) in Patients With Recurrent/Metastatic Squamous Cell Carcinomas of the Head and Neck Previously Treated With Immune Checkpoint Inhibitors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects of durvalumab, tremelimumab and hypofractionated radiation therapy in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving durvalumab, tremelimumab, and hypofractionated radiation therapy may work better in treating patients with recurrent or metastatic head and neck squamous cell carcinoma.

Detailed description

PRIMARY OBJECTIVE: I. To demonstrate safety and tolerability of durvalumab and tremelimumab and palliative radiation therapy in patients with recurrent metastatic squamous cell carcinomas of the head and neck previously exposed to an anti PD-1 or PDL-1 monoclonal antibody. SECONDARY OBJECTIVES: I. Measure objective response rates based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. criteria in patients receiving the durvalumab, tremelimumab and palliative radiation therapy (RT) combination. II. Determine overall and progression free survival in patients enrolled in the study. OUTLINE: Patients receive tremelimumab intravenously (IV) over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either hypofractionated, image-guided radiotherapy (HIGRT) or stereotactic body radiation therapy (SBRT) over 3 fractions every other day (QOD) during week 3. After completion of study treatment, patients are followed up at 30 days, 2, 3, 4, 6, 8, and 10 months, and then every 12 months.

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT
BIOLOGICAL	Tremelimumab	Given IV
PROCEDURE	Hypofractionated Image-Guided Radiation Therapy	Undergo HIGRT

Timeline

• Start date: 2018-05-17
• Primary completion: 2021-12-16
• Completion: 2022-01-19
• First posted: 2018-05-11
• Last updated: 2023-06-12
• Results posted: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study