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An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Sponsor: AstraZeneca
Summary
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection. Study details: Duration: \~78 months (6.5 years) from FSI to last subject visit Treatment length: up to \~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3
Official title: A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
915
Start Date
2026-07-16
Completion Date
2032-11-23
Last Updated
2026-07-22
Healthy Volunteers
No
Interventions
Dato-DXd
Dato-DXd is an ADC comprised of a recombinant humanised anti-TROP2 IgG1 mAb, MAAP-9001a, which is covalently conjugated via a cleavable drug-linker, MAAA1162a (the complex of MAAA-1181a and a maleimide tetrapeptide linker), using thioether bonds to the topoisomerase I inhibitor DXd.
Rilvegostomig
Rilvegostomig is a monovalent, bispecific, humanised, IgG1 mAb engineered with an Fc domain that carries a triple mutation (L234F/L235E/P331S) designed to reduce Fc-mediated effector functions. Rilvegostomig contains 2 distinct paratopes that bind to human TIGIT and PD-1 and inhibit binding to their respective immuno-suppressive ligands.
Durvalumab
A fully human monoclonal antibody that blocks the PD-L1 checkpoint to restore anti-tumor T-cell activity. Durvalumab is approved for Muscle invasive bladder cancer (MIBC) as perioperative regime.
Nivolumab
A fully human monoclonal antibody against PD-1, promoting anti-tumor immunity. Approved across many malignancies such as melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, hepatocellular carcinoma, and colorectal cancer (dMMR/MSI-H), often alone or with ipilimumab. It's used in several cancers, notably unresectable stage III non-small cell lung cancer after chemoradiation and extensive-stage small cell lung cancer in combination regimens, among others, and is also approved for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence in the adjuvant setting.
Pembrolizumab
A humanized monoclonal antibody targeting PD-1, enhancing T-cell-mediated immune responses against tumors. Indications span multiple cancers including melanoma, NSCLC, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H/dMMR tumors, and more.
Enfortumab vedotin
An antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 monoclonal antibody, linked via a protease-cleavable maleimide-based linker to the microtubule-disrupting agent monomethyl auristatin E (MMAE), which is conjugated through thioether bonds. Upon binding to Nectin-4-expressing cells, the ADC is internalized and releases MMAE, leading to disruption of microtubule dynamics and subsequent tumor cell death. Enfortumab vedotin is approved in urothelial cancers.
Locations (160)
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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San Francisco, California, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Albany, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Myrtle Beach, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Falls Church, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Auchenflower, Australia
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Ballarat, Australia
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Clayton, Australia
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Darlinghurst, Australia
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Elizabeth Vale, Australia
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South Brisbane, Australia
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St Albans, Australia
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Barretos, Brazil
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Curitiba, 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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Calgary, Alberta, Canada
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Abbotsford British Columbia, British Columbia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, 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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Chongqing, China
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Fuzhou, 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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Hangzhou, China
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Harbin, China
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Jinan, China
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Jinan, China
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Kunming, China
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Kunming, China
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Lanzhou, China
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Nanchang, China
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Nanjing, China
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Nanning, China
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Ningbo, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Shenyang, China
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Suining Shi, China
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Tianjin, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Xuzhou, China
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Zhengzhou, China
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Bordeaux, France
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Montpellier, France
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Paris, France
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Pierre-Bénite, France
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Poitiers, France
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Strasbourg, France
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Bochum, Germany
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Bonn, Germany
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Dresden, Germany
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Duisburg, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Hanover, Germany
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Herne, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Marburg, Germany
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Mettmann, Germany
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Münster, Germany
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Nuremberg, Germany
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Nürtingen, Germany
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Regensburg, Germany
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Rostock, Germany
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Stuttgart, Germany
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Tübingen, Germany
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Ulm, Germany
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Kolkata, India
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Kottayam, India
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Nashik, India
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Navi Mumbai, India
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New Delhi, India
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New Delhi, India
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New Delhi, India
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Bari, Italy
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Florence, Italy
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Padova, Italy
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Roma, Italy
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Rozzano, Italy
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Tricase, Italy
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Fukuoka, Japan
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Fukuoka, Japan
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Hamamatsu, Japan
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Hirosaki-shi, Japan
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Kanazawa, Japan
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Kashihara-shi, Japan
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Kawasaki-shi, Japan
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Kita-gun, Japan
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Kobe, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Osaka, Japan
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Osaka, Japan
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Toyama, Japan
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Tsukuba, Japan
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Gdansk, Poland
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Koszalin, Poland
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Poznan, Poland
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Siedlce, Poland
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Skórzewo, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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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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Seoul, South Korea
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L'Hospitalet de Llobregat, Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Santander, Spain
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Seville, Spain
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Bangkok, Thailand
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Hat Yai, Thailand
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Bristol, United Kingdom
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Cambridge, United Kingdom
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Preston, United Kingdom
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Sheffield, United Kingdom