RECRUITING

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Description

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Study Overview

Study Details

Study overview

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Condition
Locally Advanced Head and Neck Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

Research Site, Birmingham, Alabama, United States, 35233

Prescott Valley

Research Site, Prescott Valley, Arizona, United States, 86314

Springdale

Research Site, Springdale, Arkansas, United States, 72762

Los Angeles

Research Site, Los Angeles, California, United States, 90024

Orange

Research Site, Orange, California, United States, 92868

San Francisco

Research Site, San Francisco, California, United States, 94143

Santa Rosa

Research Site, Santa Rosa, California, United States, 95403

Aurora

Research Site, Aurora, Colorado, United States, 80045

Lone Tree

Research Site, Lone Tree, Colorado, United States, 80124

Fort Myers

Research Site, Fort Myers, Florida, United States, 33901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
  • * Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
  • * Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization.
  • * Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \>1 primary tumors are not eligible for the study.
  • * Participants with any of the following:
  • 1. Residual disease that needs further treatment with curative intent after definitive cCRT administration;
  • 2. LA-HNSCC that was resected before definitive cCRT
  • 3. LA-HNSCC that was treated and is recurrent at the time of screening
  • * Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
  • * Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) \> 12 weeks (84 days) prior to randomization.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Robert Haddad, MD, STUDY_CHAIR, Dana Farber Cancer Institute Massachusetts, USA

Lisa Licitra, MD, STUDY_CHAIR, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Study Record Dates

2030-05-23