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Search / Trial NCT06129864

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 23, 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.

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

0 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