RecruitingPhase 3NCT06989112

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer


Sponsor

AstraZeneca

Enrollment

600 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is comparing two treatment combinations — trastuzumab deruxtecan (an antibody-drug conjugate) plus either rilvegostomig or pembrolizumab (both immunotherapy drugs) — as first-line treatment for advanced or recurrent endometrial cancer (uterine cancer) that is HER2-expressing and mismatch repair proficient. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced (Stage III or IV) or first-recurrence endometrial cancer confirmed by tissue biopsy - Your tumor expresses HER2 (rated 2+ or 3+ on IHC testing) - Your tumor is mismatch repair proficient (pMMR) — meaning it does not have certain DNA repair defects - You have not previously received systemic therapy for this cancer **You may NOT be eligible if...** - You have a uterine sarcoma (carcinosarcomas are allowed) - Your cancer does not express HER2 or is mismatch repair deficient - You have previously been treated with systemic therapy for endometrial cancer 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

DRUGTrastuzumab deruxtecan

Experimental therapy by intravenous infusion

DRUGRilvegostomig

Experimental therapy by intravenous infusion

DRUGPembrolizumab

Immunotherapy by intravenous infusion

DRUGCarboplatin

Standard of Care (SoC) chemotherapy by intravenous infusion

DRUGPaclitaxel

Standard of Care (SoC) chemotherapy by intravenous infusion

DRUGDocetaxel

Standard of Care (SoC) chemotherapy by intravenous infusion


Locations(250)

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Duarte, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Palo Alto, California, United States

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San Francisco, California, United States

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Sylmar, California, United States

Research Site

Fort Myers, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

Research Site

West Palm Beach, Florida, United States

Research Site

Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Arlington Heights, Illinois, United States

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Evanston, Illinois, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Jackson, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Hackensack, 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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New York, New York, United States

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Charlotte, North Carolina, 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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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Abington, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Austin, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Blacktown, Australia

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East Melbourne, Australia

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Nedlands, Australia

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South Brisbane, Australia

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Wein, Austria

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Anderlecht, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Barretos, Brazil

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Belo Horizonte, Brazil

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Goiânia, Brazil

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Londrina, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, 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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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, 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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Québec, Quebec, Canada

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Fuzhou, 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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Haikou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Jinan, China

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Jinan, China

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Jining, 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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Shanghai, China

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Shantou, China

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Shenyang, China

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Shenyang, China

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Taiyuan, 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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Xi'an, China

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Xuzhou, China

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Yibin, China

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Aalborg, Denmark

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Herlev, Denmark

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København Ø, Denmark

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Odense, Denmark

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Helsinki, Finland

Research Site

Oulu, Finland

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Tampere, Finland

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Turku, Finland

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Besançon, France

Research Site

Bordeaux, France

Research Site

Caen, France

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Clermont-Ferrand, France

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Lyon, France

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Montpellier, France

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Nice, France

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Paris, France

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Plérin, France

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Poitiers, France

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Saint-Herblain, France

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Toulouse, France

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Berlin, Germany

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Chemnitz, Germany

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Dessau, Germany

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Dresden, Germany

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Essen, Germany

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Hamburg, Germany

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Kassel, Germany

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Leipzig, Germany

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Mannheim, Germany

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Marburg, Germany

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Münster, Germany

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Saarbrücken, Germany

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Catania, Italy

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Milan, Italy

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Monza, Italy

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Naples, Italy

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Reggio Emilia, Italy

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Roma, Italy

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Rome, Italy

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Torino, Italy

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Turin, Italy

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Akashi-shi, Japan

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Ginowan-shi, Japan

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Hidaka-shi, Japan

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Isehara-shi, Japan

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Kashiwa, Japan

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Kashiwa-shi, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kurume-shi, Japan

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Matsuyama, Japan

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Morioka, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Ota-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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Sunto-gun, Japan

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Tokyo, Japan

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Yokohama, Japan

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Amsterdam, Netherlands

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Leiden, Netherlands

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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Oslo, Norway

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Stavanger, Norway

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Bialystok, Poland

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Gdansk, Poland

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Lodz, Poland

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Poznan, Poland

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Siedlce, Poland

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Szczecin, Poland

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Goyang-si, 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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Seoul, South Korea

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Suwon, South Korea

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A Coruña, Spain

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Córdoba, Spain

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Donostia / San Sebastian, Spain

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El Palmar, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Palma de Mallorca, Spain

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Valencia, Spain

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Valencia, Spain

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Zaragoza, Spain

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Linköping, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Frauenfeld, Switzerland

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Liestal, Switzerland

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Sankt Gallen, Switzerland

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Zurich, Switzerland

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Bath, United Kingdom

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Cambridge, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

Research Site

Northwood, United Kingdom

Research Site

Taunton, United Kingdom

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NCT06989112


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