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Be Part of Research - Trial Details - Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
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Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Sutton London

Medical Conditions

Carcinoma
Carcinoma, Transitional Cell

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2019 Oct 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : For the control, + EV, + Nira, + Tira, and + SG arms, + RO7122290, Atezolizumab will be administered intravenously (IV) at a fixed dose of 1200 mg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

For the Atezo + Hu5F9-G4 and + TCZ arms, Atezo will be administered IV at a fixed dose of 840 mg every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.

Intervention Arm Group : Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1);Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2);Atezolizumab + Magrolimab for mUC Cohort (Stage 1);Atezolizumab + Niraparib for mUC Cohort (Stage 1);Atezolizumab + RO7122290 for mUC Cohort (Stage 1);Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1);Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2);Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2;Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2;Atezolizumab + Tiragolumab for mUC Cohort (Stage 1);Atezolizumab + Tocilizumab for mUC Cohort (Stage 1);Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1;Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1;Atezolizumab for mUC Cohort (Stage 1);Cisplatin-eligible MIBC Cohort 3 Arm 1;Cisplatin-eligible MIBC Cohort 3 Arm 2;

Intervention Type : DRUG
Intervention Description : Enfortumab vedotin will be administered at a dose of 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle.

Intervention Arm Group : Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1);Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2);

Intervention Type : DRUG
Intervention Description : Niraparib will be administered at a dose of 200 mg once daily (QD) by mouth.

Intervention Arm Group : Atezolizumab + Niraparib for mUC Cohort (Stage 1);

Intervention Type : DRUG
Intervention Description : Participants will receive an 1-mg/kg priming dose IV on Day 1 followed by three weekly IV doses of 30 mg/kg on Days 8, 15, and 22. During Cycle 2, participants will receive weekly IV doses of 30 mg/kg on Days 1, 8, 15, and 22. For all subsequent cycles, participants will receive 30 mg/kg on Days 1 and 15. Cycle = 28 days.

Intervention Arm Group : Atezolizumab + Magrolimab for mUC Cohort (Stage 1);

Intervention Type : DRUG
Intervention Description : Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21-day cycle.

Intervention Arm Group : Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2;Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2;Atezolizumab + Tiragolumab for mUC Cohort (Stage 1);Cisplatin-eligible MIBC Cohort 3 Arm 2;

Intervention Type : DRUG
Intervention Description : Sacituzumab Govitecan will be administered at a dose of 10 mg/kg by IV on Day 1 and 8 of each 21-day cycle.

Intervention Arm Group : Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1);Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2);

Intervention Type : DRUG
Intervention Description : Tocilizumab will be administered by IV infusion at a dose of 8 mg/kg every 4 weeks (Q4W) on Day 1 of each 28-day cycle.

Intervention Arm Group : Atezolizumab + Tocilizumab for mUC Cohort (Stage 1);

Intervention Type : DRUG
Intervention Description : Cisplatin will be administered at a dose of 70mg/m\^2 by IV on Day 1 of each cycle for Cycles 1-3 pre-surgery.

Intervention Arm Group : Cisplatin-eligible MIBC Cohort 3 Arm 1;Cisplatin-eligible MIBC Cohort 3 Arm 2;

Intervention Type : DRUG
Intervention Description : Gemcitabine will be administered at a dose of 1000mg/m\^2 by IV on Days 1 and 8 of each cycle for Cycles 1-3 pre-surgery.

Intervention Arm Group : Cisplatin-eligible MIBC Cohort 3 Arm 1;Cisplatin-eligible MIBC Cohort 3 Arm 2;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Marsden NHS Foundation Trust
    Sutton
    SM2 5PT
  • Barts and The London
    London
    EC1M 6BQ


The study is sponsored by Hoffmann-La Roche and is in collaboration with Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas.



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Read full details for Trial ID: NCT03869190
Last updated 02 April 2025

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