Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
1/2상
조기 종료
NCT03869190
| 대상 질환 | Urothelial Carcinoma, Bladder Cancer |
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| 임상 단계 | 1/2상 |
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| 스폰서 | Hoffmann-La Roche |
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| 상태 | 조기 종료 |
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| 참여자 수 | 272 명 |
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| 중재(약물) | Atezolizumab, Enfortumab Vedotin, Niraparib, Magrolimab (Hu5F9-G4), Tiragolumab |
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| 시작일 | 2019년 6월 1일 |
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| 완료일 | 2025년 10월 8일 |
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| 결과 공개일 | 2026년 8월 3일 |
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요약
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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BENITIONS에서 보기
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