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A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma Morpheus-UC
EU CTIS ID: 2024-511316-25-00
What this study is testing
Metastatic urothelial carcinoma cohort (mUC) cohort: To evaluate the efficacy of immunotherapy-based treatment combinations during Stage 1 based on Objective response rate MIBC cohorts: To evaluate the efficacy of treatment in patients treated perioperatively for MIBC based on pathologic complete response
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Stage 1: Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1 (PD-L1) and/or additional biomarker status by means of central testing
- Stage 1: Disease progression during or following treatment with no more than one platinum containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
- Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST) v1.1
- Stage 1 and Stage 2 Negative HIV test at screening
- For the Muscle Invasive Bladder Cancer Cohorts (MIBC) Availability of a TURBT specimen that is suitable for determination of PD-L1 and additional biomarker status by means of central testing
- For the Muscle Invasive Bladder Cancer Cohorts (MIBC) N0 or M0 disease assessed by CT or magnetic resonance imaging (MRI) scan (within 4 weeks of study treatment initiation)
You likely can't join if
- For mUC cohort: Stage 1 Prior treatment with a T-cell co-stimulating therapy or an immune checkpoint inhibitor, or investigational therapy within 28 days before C1D1, or any approved anti-cancer therapy within 3 weeks before study
- For mUC cohort: Stage 1 and Stage 2 Prior systemic immunostimulatory treatments within 4 weeks or 5 half-lives of the drug before study, or with systemic immunosuppressants within 2 weeks before study, or need such during study
- For mUC cohort: Stage 1 and Stage 2 History of leptomeningeal disease, autoimmune disease, idiopathic pulmonary fibrosis (IPF), organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or active pneumonitis at screening
- For mUC cohort: Stage 1 and Stage 2 Active tuberculosis (TB)
- For MIBC Cohorts Received a live, attenuated vaccine within 4 weeks before study, or needing such during atezolizumab treatment or within 5 months after the last dose
- For MIBC Cohorts Active or history of autoimmune disease or immune deficiency
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
- United States
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of; United States; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.