A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
Launched by ASTRAZENECA · Nov 10, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called volrustomig for patients with a type of cancer called unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This trial is for individuals who have already received a specific type of treatment known as definitive concurrent chemoradiotherapy (cCRT) and have not seen their cancer worsen in the past 12 weeks. The goal is to find out if volrustomig is more effective and safer than simply observing the patient's condition without any additional treatment.
To be eligible for this trial, participants must have been diagnosed with advanced head and neck cancer that has not spread to other parts of the body and must not have had any surgery to remove the tumor. The trial is open to adults aged 18 and older, regardless of gender. If someone decides to join the trial, they can expect regular check-ins and monitoring to assess their health and how well the treatment works. It's important to note that this study is currently recruiting, so interested individuals can reach out for more information on how to participate.
Gender
ALL
Eligibility criteria
- Inclusion 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.
- Exclusion Criteria:
- • 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Los Angeles, California, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Birmingham, Alabama, United States
Spokane, Washington, United States
Towson, Maryland, United States
Norfolk, Virginia, United States
Edegem, , Belgium
Barretos, , Brazil
Nyíregyháza, , Hungary
Aviano, , Italy
Białystok, , Poland
Aurora, Colorado, United States
Tacoma, Washington, United States
Portland, Oregon, United States
Albuquerque, New Mexico, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Salt Lake City, Utah, United States
Villejuif, , France
Milano, , Italy
Manchester, , United Kingdom
San Francisco, California, United States
Gainesville, Florida, United States
Cleveland, Ohio, United States
Charlotte, North Carolina, United States
Namur, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Bordeaux, , France
Napoli, , Italy
Padova, , Italy
Warszawa, , Poland
Budapest, , Hungary
Miskolc, , Hungary
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Salzburg, , Austria
Charleroi, , Belgium
Kingston, Ontario, Canada
Essen, , Germany
Hannover, , Germany
Kansas City, Kansas, United States
Ann Arbor, Michigan, United States
Orange, California, United States
London, , United Kingdom
Los Angeles, California, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Hackensack, New Jersey, United States
Winston Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Berlin, , Germany
Hamburg, , Germany
Pavia, , Italy
Leeds, , United Kingdom
Shreveport, Louisiana, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Sutton, , United Kingdom
Nashville, Tennessee, United States
München, , Germany
Badalona, , Spain
Northwood, , United Kingdom
New Delhi, , India
Austin, Texas, United States
Tyler, Texas, United States
Pittsburgh, Pennsylvania, United States
Bangkok, , Thailand
Budapest, , Hungary
Kecskemét, , Hungary
West Palm Beach, Florida, United States
Rostock, , Germany
Madrid, , Spain
Wirral, , United Kingdom
Stony Brook, New York, United States
Regina, , Canada
Leipzig, , Germany
Fort Myers, Florida, United States
Santa Rosa, California, United States
Sioux Falls, South Dakota, United States
Beijing, , China
Baltimore, Maryland, United States
Ijuí, , Brazil
Rozzano, , Italy
Firenze, , Italy
Valencia, , Spain
Modena, , Italy
Tianjin, , China
London, Ontario, Canada
Sapporo Shi, , Japan
Goyang Si, , Korea, Republic Of
Niles, Illinois, United States
Des Moines, Iowa, United States
Thiruvananthapuram, , India
Nagoya Shi, , Japan
Taipei, , Taiwan
Columbia, Maryland, United States
Richmond, Virginia, United States
Kelowna, British Columbia, Canada
Chuo Ku, , Japan
Niigata Shi, , Japan
Dallas, Texas, United States
Chongqing, , China
Nanning, , China
Xian, , China
Pécs, , Hungary
Szekszárd, , Hungary
Kuching, , Malaysia
Changhua, , Taiwan
Toulouse Cedex 09, , France
Kashiwa, , Japan
Koto Ku, , Japan
Sunto Gun, , Japan
Tübingen, , Germany
Greifswald, , Germany
Ulm, , Germany
Kunming, , China
Lyon, , France
Sendai Shi, , Japan
La Louvière, , Belgium
Guangzhou, , China
Valencia, , Spain
Chiba Shi, , Japan
Hyattsville, Maryland, United States
Seoul, , Korea, Republic Of
London, , United Kingdom
Lone Tree, Colorado, United States
West Jordan, Utah, United States
Miami, Florida, United States
Odessa, Texas, United States
Yokohama Shi, , Japan
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
York, Pennsylvania, United States
Changsha, , China
Aberdeen, , United Kingdom
Ho Chi Minh, , Vietnam
Okayama Shi, , Japan
Ankara, , Turkey
Saint Herblain, , France
Bengbu, , China
Changchun, , China
Fuzhou, , China
Hangzhou, , China
Urumqi, , China
Wuhan, , China
Zhengzhou, , China
Győr, , Hungary
Osaka Shi, , Japan
East Brunswick, New Jersey, United States
Porto Alegre, , Brazil
Hat Yai, , Thailand
Antalya, , Turkey
Incheon, , Korea, Republic Of
Lübeck, , Germany
Jaén, , Spain
Springdale, Arkansas, United States
Suwon, , Korea, Republic Of
Hiroshima Shi, , Japan
Harbin, , China
Khon Kaen, , Thailand
Taipei City, , Taiwan
Taichung, , Taiwan
Lucknow, , India
Osakasayama Shi, , Japan
Hefei, , China
Rio De Janeiro, , Brazil
Kobe Shi, , Japan
Bielsko Biała, , Poland
Florianópolis, , Brazil
Sao Paulo, , Brazil
Taunton, , United Kingdom
Istanbul, , Turkey
Xiamen, , China
Fortaleza, , Brazil
Würzburg, , Germany
Madurai, , India
Wien, , Austria
New York, New York, United States
Gyeonggi Do, , Korea, Republic Of
Nanchang, , China
Fukuoka, , Japan
Karsiyaka, , Turkey
Avignon Cedex 09, , France
Flower Mound, Texas, United States
Tomaszów Mazowiecki, , Poland
George Town, , Malaysia
Kuala Lumpur, , Malaysia
Johor Bahru, , Malaysia
Chengdu, , China
Piotrków Trybunalski, , Poland
València, , Spain
Bunkyo Ku, , Japan
Hyderabad, , India
Londrina, , Brazil
Shiwa Gun, , Japan
Teresina, , Brazil
Guiyang, , China
Morioka, , Japan
Jinan, , China
Selangor, , Malaysia
Baton Rouge, Louisiana, United States
Kolkata, , India
Ribeirão Preto, , Brazil
Mohali, , India
Kanpur, , India
Gliwice, , Poland
Prescott Valley, Arizona, United States
Montreal, Quebec, Canada
Hampshire, , United Kingdom
Jaipur, , India
Vadodara, , India
Shenyang, , China
Ipatinga, , Brazil
Palm Bay, Florida, United States
Jette, , Belgium
Varanasi, , India
Bengaluru, , India
Cambridge, , United Kingdom
Yenimahalle, , Turkey
Kaohsiung City, , Taiwan
Tacoma, Washington, United States
Chaing Mai, , Thailand
Kochi, , India
Vinh, , Vietnam
Columbia, Missouri, United States
Tianjin Shi, , China
Upper Marlboro, Maryland, United States
Shanghai, , China
Wuxi, , China
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported