A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma Morpheus-UC
Key facts
- Where
- Barcelona, Córdoba és Madrid, SpanyolországSee the 6 sites
- Phase
- 1. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- ICO l'Hospitalet - Hospital Duran i ReynalsBarcelona, SpanyolországNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario HM SanchinarroMadrid, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2024-511316-25-00
- Record updated
- 2026. január 20.
- Original description
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 responseRead full original descriptionShow less
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma (MORPHEUS-UC)
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
Inclusion: 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).
Exclusion: 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 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 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 Active or history of autoimmune disease or immune deficiency.