Dato-DXd plus rilvegostomig after high-risk MIUC surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, open-label trial compares a combination therapy (Dato-DXd with rilvegostomig) to standard-of-care in adults with high-risk muscle-invasive urothelial carcinoma who have completed radical resection with no detectable disease. Participants are randomized to receive the investigational regimen or standard therapies, with treatment cycles every 2–3 weeks in the experimental arms and tailored intervals in the control arm, for up to about 12 months. The study emphasizes safety and efficacy outcomes, with central testing on archival tumor tissue and eligibility defined by resection status and performance status. Conduct sites are in Arkansas, led by AstraZeneca with Daiichi Sankyo collaboration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Barrie, Ontario, Canada Recruiting
• Research Site
  Hamilton, Ontario, Canada Recruiting
• Research Site
  Kaohsiung City, Taiwan Recruiting
• Research Site
  Hot Springs, Arkansas, United States Not yet recruiting
• Research Site
  Little Rock, Arkansas, United States Not yet recruiting
• Research Site
  Little Rock, Arkansas, United States Not yet recruiting

+110 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.