Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
第1/2相
早期終了
NCT03869190
| 対象疾患 | Urothelial Carcinoma, Bladder Cancer |
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| 相 | 第1/2相 |
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| スポンサー | Hoffmann-La Roche |
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| ステータス | 早期終了 |
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| 参加者数 | 272 名 |
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| 介入（薬剤） | Atezolizumab, Enfortumab Vedotin, Niraparib, Magrolimab (Hu5F9-G4), Tiragolumab |
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| 開始日 | 2019年6月1日 |
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| 完了日 | 2025年10月8日 |
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| 結果公開日 | 2026年8月3日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
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