RecruitingPhase 3NCT06129864

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

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)

Sponsor

AstraZeneca

Enrollment

1,145 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This global trial is studying a new immunotherapy drug called Volrustomig (MEDI5752) — which blocks both PD-1 and CTLA-4 checkpoints simultaneously — as a maintenance treatment for patients with locally advanced, unresected head and neck squamous cell carcinoma (HNSCC) after they have completed chemoradiation therapy. **You may be eligible if:** - You have confirmed locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx (Stage III, IVA, or IVB) with no distant spread - Your tumor was not surgically removed before chemoradiation - You have completed definitive chemotherapy plus radiation with curative intent **You may NOT be eligible if:** - Your cancer is from a different head and neck location (e.g., nasopharynx, salivary gland, or unknown primary) - You have more than one primary tumor - Your cancer had already been surgically removed before chemoradiation - Your cancer has already come back (recurrent) at the time of screening - You received radiation therapy alone (without chemotherapy) as your primary treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGvolrustomig

volrustomig

Locations(305)

Research Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Prescott Valley, Arizona, United States

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Springdale, Arkansas, United States

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Fountain Valley, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Whittier, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Lone Tree, Colorado, United States

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Washington D.C., District of Columbia, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Palm Bay, Florida, United States

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West Palm Beach, Florida, United States

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Niles, Illinois, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Hyattsville, Maryland, United States

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Towson, Maryland, United States

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Upper Marlboro, Maryland, United States

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Boston, Massachusetts, United States

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Fairhaven, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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East Brunswick, New Jersey, United States

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Hackensack, New Jersey, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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York, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Sioux Falls, South Dakota, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Flower Mound, Texas, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Salzburg, Austria

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Vienna, Austria

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Charleroi, Belgium

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Edegem, Belgium

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Jette, Belgium

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La Louvière, Belgium

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Namur, Belgium

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Barretos, Brazil

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Florianópolis, Brazil

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Fortaleza, Brazil

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Ijuí, Brazil

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Ipatinga, Brazil

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Londrina, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Teresina, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Regina, Canada

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Beijing, China

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Beijing, China

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Bengbu, China

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Changchun, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Chongqing, China

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Dongwan, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guiyang, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Huizhou, China

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Jinan, China

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Kunming, China

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Lanzhou, China

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Nanchang, China

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Nanning, China

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Shanghai, China

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Shenyang, China

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Shijiazhuang, China

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Tianjin, China

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Tianjin, China

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Ürümqi, China

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Wuhan, China

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Wuhan, China

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Wuxi, China

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Xi'an, China

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Xiamen, China

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Zhengzhou, China

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Zhuhai, China

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Avignon, France

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Bordeaux, France

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Le Mans, France

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Lyon, France

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Nice, France

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Saint-Herblain, France

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Toulouse, France

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Villejuif, France

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Berlin, Germany

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Erlangen, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Greifswald, Germany

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Hamburg, Germany

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Hanover, Germany

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Leipzig, Germany

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Lübeck, Germany

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München, Germany

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Rostock, Germany

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Tübingen, Germany

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Ulm, Germany

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Würzburg, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Győr, Hungary

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Gyula, Hungary

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Kecskemét, Hungary

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Miskolc, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Szekszárd, Hungary

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Bengaluru, India

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Hyderabad, India

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Jaipur, India

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Kanpur, India

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Kochi, India

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Kolkata, India

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Lucknow, India

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Madurai, India

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Mohali, India

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Nashik, India

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New Delhi, India

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Thiruvananthapuram, India

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Vadodara, India

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Varanasi, India

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Aviano, Italy

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Florence, Italy

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Milan, Italy

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Modena, Italy

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Naples, Italy

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Padova, Italy

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Pavia, Italy

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Rozzano, Italy

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Bunkyō City, Japan

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Bunkyō City, Japan

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Chiba, Japan

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Chiba, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Hidaka-shi, Japan

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Hiroshima, Japan

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Kashiwa, Japan

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Kobe, Japan

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Kōtoku, Japan

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Nagoya, Japan

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Nagoya, Japan

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Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Sagamihara-shi, Japan

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Sapporo, Japan

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Sendai, Japan

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Shinjuku-ku, Japan

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Shiwa-gun, Japan

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Sunto-gun, Japan

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Yokohama, Japan

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Yokohama, Japan

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George Town, Malaysia

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Kuching, Malaysia

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Cebu City, Philippines

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General Santos, Philippines

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Iloilo City, Philippines

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Manila, Philippines

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Pasig, Philippines

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Quezon City, Philippines

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West San Juan City, Philippines

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Bialystok, Poland

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Bielsko-Biala, Poland

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Bydgoszcz, Poland

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Gliwice, Poland

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Olsztyn, Poland

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Piotrkow Trybunalski, Poland

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Siedlce, Poland

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Tomaszów Mazowiecki, Poland

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Warsaw, Poland

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San Juan, Puerto Rico

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Badalona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Jaén, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Valencia, Spain

Research Site

Valencia, Spain

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

Research Site

Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chaing Mai, Thailand

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Hat Yai, Thailand

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Khon Kaen, Thailand

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Lampang, Thailand

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Muang, Thailand

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Mueang, Thailand

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Cordaleo, Turkey (Türkiye)

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Eskişehir, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Yenimahalle, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Cambridge, United Kingdom

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Hampshire, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Metropolitan Borough of Wirral, United Kingdom

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Northwood, United Kingdom

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Sutton, United Kingdom

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Taunton, United Kingdom

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Da Nang, Vietnam

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Hanoi, Vietnam

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Hà Nội, Vietnam

Research Site

Ho Chi Minh City, Vietnam

Research Site

Huế, Vietnam

Research Site

Vinh, Vietnam

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NCT06129864

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