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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511316-25-00

Acronym

WO39613

Enrollment

220

Registered

2024-07-05

Start date

2019-06-04

Completion date

2025-11-12

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma (UC)

Brief summary

1. Objective response rate (mUC Cohort), 2. Pathological complete response (MIBC Cohorts)

Detailed description

1. Progression-free survival, 2. Overall survival after randomization, 3. Overall survival rate at specific time points, 4. Duration of response, 5. Disease control, 6. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, 7. Change from baseline in vital signs, 8. Change from baseline in targeted clinical laboratory test results MIBC Cohorts, 9. Landmark recurrence-free survival, event-free survival and overall survival MIBC Cohorts, 10. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0

Interventions

DRUGTiragolumab

DRUGCISPLATIN

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGGEMCITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Objective response rate (mUC Cohort), 2. Pathological complete response (MIBC Cohorts)	—

Secondary

Measure	Time frame
1. Progression-free survival, 2. Overall survival after randomization, 3. Overall survival rate at specific time points, 4. Duration of response, 5. Disease control, 6. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, 7. Change from baseline in vital signs, 8. Change from baseline in targeted clinical laboratory test results MIBC Cohorts, 9. Landmark recurrence-free survival, event-free survival and overall survival MIBC Cohorts, 10. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0	—

Measure

Time frame

—

Countries

France, Greece, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026