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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

September 4, 2025

Study Completion Date

October 15, 2025

Conditions
Urothelial CarcinomaBladder Cancer
Interventions
DRUG

Atezolizumab

"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."

DRUG

Enfortumab Vedotin

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

DRUG

Niraparib

Niraparib will be administered at a dose of 200 mg once daily (QD) by mouth.

DRUG

Magrolimab (Hu5F9-G4)

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.

DRUG

Tiragolumab

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

DRUG

Sacituzumab Govitecan

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

DRUG

Tocilizumab

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.

DRUG

Cisplatin

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.

DRUG

Gemcitabine

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.

Trial Locations (34)

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

11725

Memorial Sloan-Kettering Cancer Center, Commack

12462

Attiko Hospital University of Athens, Athens

14004

Hospital Universitario Reina Sofia, Córdoba

14076

Centre Francois Baclesse, Caen

15706

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

28009

Hospital General Universitario Gregorio Mara, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz., Madrid

28041

Hospital Univ 12 de Octubre, Madrid

28050

START Madrid. Centro Integral Oncologico Clara Campal, Madrid

28204

Levine Cancer Institute, Charlotte

31008

Clinica Universitaria de Navarra, Pamplona

31052

Institut Claudius Regaud, Toulouse

34298

Institut régional du Cancer Montpellier, Montpellier

40241

Norton Cancer Institute, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

44016

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

46010

Hospital Clinico Universitario de Valencia, Valencia

69008

Centre Leon Berard, Lyon

90024

UCLA Department of Medicine, Los Angeles

94115

UCSF Comprehensive Cancer Ctr, San Francisco

94305-5820

Stanford Cancer Center, Stanford

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

151 25

Athens Medical Center, Athens

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

120-749

Severance Hospital, Seoul

08908

ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO, L'Hospitalet de Llobregat

08035

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

EC1M 6BQ

Barts and The London, London

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
collaborator

Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas

UNKNOWN

lead

Hoffmann-La Roche

INDUSTRY

NCT03869190 - Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) | Biotech Hunter | Biotech Hunter