Comparing 3 approaches for high-risk muscle invasive urothelial carcinoma

Exclusion

• −Known history of severe hypersensitivity reactions to any study drug
• −Active or uncontrolled hepatitis B or C virus infection.
• −Known HIV infection that is not well controlled.
• −Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
• −Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
• −Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
• −History of clinically significant corneal disease.
• −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.
• −Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baselineBaselineYour starting measurements, taken before treatment begins.Read more →. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care.
• −Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
• −Has clinically severe pulmonary function compromise.
• −Mean resting corrected QTcF \> 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Uncontrolled or significant cardiac conditions.
• −Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
• −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.
• −Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
• −Not eligible to receive at least one of SoCStandard of careThe treatment normally given for a condition outside a study.Read more → according to local regulations/approvals.
• −Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
• −Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
• −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.