CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 18 enrolled / 18 target
Drug / intervention
Durvalumab +1 moredrug
Likely dose
Durvalumab 1500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03529422
NCT03529422Phase 2ActiveUpdate Overdue (0.2/mo)Completion was 24mo ago

A Phase II Study of Durvalumab (MEDI 4736) With Radiotherapy for the Adjuvant Treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma

UNC Lineberger Comprehensive Cancer Center·interventional·Posted May 18, 2018·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Durvalumab and Intensity Modulated Radiotherapy Treatments for Larynx and 3 related conditions. Active but no longer recruiting, targeting 18 participants across 3 sites.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients. Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2Active
20192020202120222023202420252026
First PostedMay 18, 2018
Enrollment StartOct 7, 2019
Primary CompletionJul 1, 2024
Study CompletionAug 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.1 years ago

Arms & Interventions

Open-label, single-armother

Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments

Drug: DurvalumabRadiation: Intensity Modulated Radiotherapy Treatments

Interventions

Durvalumabdrug

Durvalumab 1500mg IV every 3 weeks for 6 cycles

Intensity Modulated Radiotherapy Treatmentsradiation

Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks