Comparing 8 approaches for urothelial carcinoma

Exclusion

• −Known hypersensitivity to disitamab vedotin or any of their components
• −Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
• −Known hypersensitivity to disitamab vedotin or any of their components
• −Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
• −Known hypersensitivity to disitamab vedotin or any of their components
• −CohortsCohortA group of participants sharing a characteristic, followed together.Read more → A and B
• −Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
• −Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
• −Peripheral sensory or motor neuropathy ≥ Grade 2 at baselineBaselineYour starting measurements, taken before treatment begins.Read more →
• −Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
• −Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
• −Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
• −Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
• −Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.
• −Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
• −Prior HER2-directed therapy
• −Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
• −Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
• −Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
• −Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
• −Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
• −Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
• −Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
• −Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
• −Prior HER2-directed therapy
• −Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
• −There are additional inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →. The study center will determine if criteria for participation are met.
• −Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)
• −Major surgery that has not fully recovered within 4 weeks prior to dose administration
• −Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-armArmOne of the groups in a study, each receiving something different.Read more → part of Cohort C and as randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → date for the randomized part of Cohort C)
• −Major surgery that has not fully recovered within 4 weeks prior to dose administration
• −Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)
• −Major surgery that has not fully recovered within 4 weeks prior to dose administration
• −Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)
• −Major surgery that has not fully recovered within 4 weeks prior to dose administration
• −Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)
• −Major surgery that has not fully recovered within 4 weeks prior to dose administration