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NCT03869190 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 272
- Enrollment target
NCT03869190: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03869190 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 272 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (353% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03869190, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 272 participants
- Enrollment target
Study 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.
Primary Outcome
ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or n
Interventions
- DRUG Atezolizumab
- DRUG Enfortumab Vedotin
- DRUG Niraparib
- DRUG Tiragolumab
- DRUG Magrolimab (Hu5F9-G4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 1 |
What the finished NCT03869190 record still lists
NCT03869190 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (353% higher).
The record links to 0 conditions, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03869190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03869190 about?
NCT03869190 is a clinical study titled "Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)". 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...
What is the current status of trial NCT03869190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 272 participants. The study started on 2019-06-01. Estimated completion is 2025-12-22.
What interventions are being tested in trial NCT03869190?
The interventions under investigation include: Atezolizumab (DRUG), Enfortumab Vedotin (DRUG), Niraparib (DRUG), Tiragolumab (DRUG), Magrolimab (Hu5F9-G4) (DRUG).
Who is sponsoring clinical trial NCT03869190?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03869190's enrollment target sits among peer trials
272 149th of 2000 higher than 1,851 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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