Can a Two-Drug cocktail keep bladder cancer from coming back?

NCT ID NCT07720284

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a combination of two drugs—datopotamab deruxtecan and rilvegostomig—given after surgery can prevent cancer recurrence in people with high-risk muscle invasive bladder cancer. Participants who have had their tumor completely removed will receive either the drug combo or standard care. The study aims to see if the combination improves how long people stay cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: a combination of two drugs: datopotamab deruxtecan (an antibody-drug conjugate targeting TROP2) and rilvegostomig (a bispecific antibody)
What this could lead to: If successful, this combination could offer a new option to reduce the risk of cancer returning after surgery for people with high-risk bladder cancer.
What could go wrong: This is an early-stage test of a new combination; side effects from the drugs could be significant, and it may not prove more effective than current standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 915 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Participant must be \> 18 years of age at the time of signing the ICF. 2. Histologically confirmed MIUC of the bladder or upper tract. 3. Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease. 4. Pathologic evidence of urothelial carcinoma at high-risk of recurrence and 1. not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage 2. completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage 5. No evidence of disease at screening, 6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation. 7. Minimum life expectancy of \> 12 weeks at time of screening. 8. An archival surgical tumour sample must be available pre-randomisation for central testing. 9. Adequate organ and bone marrow function within 28 days before randomisation. Exclusion criteria: 1. Any tumour with predominant or pure high grade neuroendocrine carcinoma component. 2. Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy. 3. Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma. 4. Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse. 5. History of clinically significant corneal disease. 6. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence. 7. Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care. 8. Active or uncontrolled hepatitis B or C virus infection. 9. Known HIV infection that is not well controlled. 10. Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation. 11. History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 12. Has clinically severe pulmonary function compromise. 13. Mean resting corrected QTcF \> 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening 14. Uncontrolled or significant cardiac conditions. 15. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years. 16. Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms. 17. Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation. 18. Known history of severe hypersensitivity reactions to any study drug 19. Not eligible to receive at least one of SoC according to local regulations/approvals. 20. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

carcinoma infiltrating bladder urothelial carcinoma transitional cell carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-risk muscle invasive urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

155 sites in 16 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72211, United States
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San Francisco, California, 94143, United States
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Chicago, Illinois, 60637, United States
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Boston, Massachusetts, 02215, United States
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Kansas City, Missouri, 64132, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68130, United States
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Albany, New York, 12208, United States
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New York, New York, 10065, United States
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Cleveland, Ohio, 44195, United States
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Myrtle Beach, South Carolina, 29572, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75235, United States
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Falls Church, Virginia, 22042, United States
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Seattle, Washington, 98109, United States
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Tacoma, Washington, 98405, United States
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Milwaukee, Wisconsin, 53226, United States
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Auchenflower, 4066, Australia
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Ballarat, 3350, Australia
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Clayton, 3168, Australia
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Darlinghurst, 2010, Australia
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Elizabeth Vale, 5112, Australia
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South Brisbane, 4101, Australia
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St Albans, 3021, Australia
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Barretos, 14784-400, Brazil
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Curitiba, 81520-060, Brazil
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Salvador, 41950-640, Brazil
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São Paulo, 01323-903, Brazil
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São Paulo, 05652-900, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Abbotsford British Columbia, British Columbia, V2S0C2, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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London, Ontario, N6C 2R5, Canada
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Mississauga, Ontario, L5M 2N1, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Beijing, 100034, China
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Beijing, 100050, China
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Beijing, 100191, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400016, China
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Chongqing, 400030, China
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Fuzhou, 350005, China
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Guangzhou, 510220, China
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Guangzhou, 510288, China
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Guiyang, 550044, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Harbin, 150049, China
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Jinan, 250012, China
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Jinan, 250021, China
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Kunming, 650101, China
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Kunming, 650118, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210008, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Qingdao, 266003, China
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Shanghai, 200040, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Suining Shi, 629000, China
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Tianjin, 300211, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xuzhou, 221000, China
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Zhengzhou, 450008, China
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Bordeaux, 33000, France
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Montpellier, 34298, France
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Paris, 75014, France
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Pierre-Bénite, 69310, France
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Poitiers, 86000, France
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Strasbourg, 67098, France
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Bochum, 44791, Germany
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Bonn, 53127, Germany
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Dresden, 01307, Germany
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Duisburg, 47169, Germany
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Frankfurt am Main, 60431, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Herne, 44625, Germany
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Magdeburg, 39120, Germany
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Mannheim, 68167, Germany
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Marburg, 35043, Germany
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Mettmann, 40822, Germany
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Münster, 48149, Germany
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Nuremberg, 90419, Germany
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Nürtingen, 72622, Germany
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Regensburg, 93053, Germany
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Rostock, 18057, Germany
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Stuttgart, 70174, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Kolkata, 700160, India
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Kottayam, 686008, India
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Nashik, 422011, India
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Navi Mumbai, 410210, India
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New Delhi, 110076, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Bari, 70120, Italy
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Florence, 50134, Italy
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Padova, 35128, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Tricase, 73039, Italy
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Fukuoka, 811-1347, Japan
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Fukuoka, 812-8582, Japan
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Hamamatsu, 431-3192, Japan
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Hirosaki-shi, 036-8563, Japan
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Kanazawa, 920-8641, Japan
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Kashihara-shi, 634-8522, Japan
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Kawasaki-shi, 216-8511, Japan
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Kita-gun, 761-0793, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-0008, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Toyama, 930-0194, Japan
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Tsukuba, 305-8576, Japan
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Gdansk, 80-952, Poland
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Koszalin, 75-581, Poland
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Poznan, 61-731, Poland
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Siedlce, 08-110, Poland
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Skórzewo, 60-185, Poland
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Wroclaw, 50-556, Poland
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Wroclaw, 53-413, Poland
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Seoul, 03080, South Korea
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Seoul, 06591, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Seoul, 6351, South Korea
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L'Hospitalet de Llobregat, 08908, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 28040, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 813, Taiwan
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Kaohsiung City, 83301, Taiwan
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Tainan, 704, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Bristol, BS2 8ED, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Sheffield, S10 2SJ, United Kingdom

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