For Healthcare Professionals

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

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About 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

for mUC Cohort:

  1. Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
  2. Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
  3. Disease progression during or following treatment with no more than one platinum-containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
  4. ECOG Performance Status of 0 or 1
  5. Measurable disease (at least one target lesion) according to RECIST v1.1
  6. Adequate hematologic and end-organ function
  7. Negative HIV test at screening
  8. Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV) antibody at screening
  9. Tumor accessible for biopsy
  10. For women of childbearing potential: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating eggs
  11. For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall 888-662-6728 (U.S. Only)Email iconEmail Study Center

    Study’s details


    Contition

    Bladder Cancer,Urothelial Carcinoma

    Age

    18+

    Phase

    Phase 1/Phase 2

    Participants needed

    645

    Est. Completion Date

    Nov 2027

    Treatment type

    Interventional


    Sponsor

    Hoffmann-La Roche

    ClinicalTrials.gov identifier

    NCT03869190

    Study number

    WO39613

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