Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
Phase 1/2
Terminated
NCT03869190
| Condition | Urothelial Carcinoma, Bladder Cancer |
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| Phase | Phase 1/2 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Terminated |
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| Enrollment | 272 participants |
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| Interventions | Atezolizumab, Enfortumab Vedotin, Niraparib, Magrolimab (Hu5F9-G4), Tiragolumab |
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| Start date | Jun 1, 2019 |
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| Completion date | Oct 8, 2025 |
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| Results posted | Aug 3, 2026 |
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Summary
A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.
Stage 1 mUC Cohorts: Objective Response Rate (ORR)
Up to 61.5 months · percentage of participants
| Stage 1 mUC Cohort: Atezo (Control) | 27.6 percentage of participants |
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| Stage 1 mUC Cohort: Atezo + EV | 26.7 percentage of participants |
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| Stage 1 mUC Cohort: Atezo + Hu5F9-G4 | 26.7 percentage of participants |
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| Stage 1 mUC Cohort: Atezo + Nira | 6.7 percentage of participants |
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| Stage 1 mUC Cohort: Atezo + RO7122290 | 16.7 percentage of participants |
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| Stage 1 mUC Cohort: Atezo + SG | 6.7 percentage of participants |
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| Difference in Overall Response Rates | -0.92 (95% CI -33.64–31.80) |
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MIBC Cohorts: Pathological Complete Response (pCR)
Up to 17.8 months · percentage of participants
| Stage 1 MIBC Cohort 1: Atezo (Control) | 66.7 percentage of participants |
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| Stage 1 MIBC Cohort 1: Atezo + Tira | 27.3 percentage of participants |
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| Stage 1 MIBC Cohort 2: Atezo (Control) | 21.7 percentage of participants |
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| Stage 1 MIBC Cohort 2: Atezo + Tira | 20.0 percentage of participants |
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| Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control) | 27.8 percentage of participants |
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| Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira | 23.5 percentage of participants |
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| Difference in pCR Rates | -39.39 (95% CI -98.27–19.48) |
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Open in BENITIONS
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