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BRIEF TITLE: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (MORPHEUS-mUC)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (MORPHEUS-mUC)


  • Org Study ID: WO39613
  • Secondary ID:
  • NCT ID: NCT03869190
  • NCT Alias:
  • Sponsor: Hoffmann-La Roche - Industry
  • Source: Hoffmann-La Roche

Brief Summary

A Phase Ib/II, open-label, multicenter, randomized, umbrella study 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).

Overal Status Start Date Phase Study Type
Recruiting June 1, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate (ORR)

Primary Outcome 1 - Time Frame: Baseline until disease progression or loss of clinical benefit (approximately 4 years)

Condition:

  • Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- 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)

- Availability of a representative tumor specimen that is suitable for determination of
PD-L1 and/or additional biomarker status by means of central testing

- Disease progression during or following treatment with no more than one
platinum-containing regimen for inoperable, locally advanced or metastatic UC or
disease recurrence

- ECOG Performance Status of 0 or 1

- Measurable disease (at least one target lesion) according to RECIST v1.1

- Adequate hematologic and end-organ function

- Negative HIV test at screening

- Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV)
antibody at screening

- Tumor accessible for biopsy

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive measures and agreement to refrain from donating eggs

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm

Exclusion Criteria:

- Prior treatment with a T-cell co-stimulating therapy or a CPI including anti-CTLA-4,
anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Prior treatment with any of the protocol-specified study treatments including
treatment with poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor,
nectin-4 targeting agents, signal regulatory protein alpha-targeting agents, or agents
that block CD38

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3
weeks prior to initiation of study treatment

- Eligibility only for the control arm

- Prior allogeneic stem cell or solid organ transplantation

- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
drug (whichever is longer) prior to the initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment or anticipation of need for systemic immunosuppressant
medication during study treatment

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment or
within 5 months after the last dose of atezolizumab

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

- History of malignancy other than UC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
of study treatment

- Significant cardiovascular disease

- Grade 3 or greater hemorrhage or bleeding event within 28 days prior to initiation of
study treatment

- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
of study treatment

- Pregnancy or breastfeeding, or intention of becoming pregnant during the study

- Additional drug-specific exclusion criteria might apply
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Reference Study ID Number: WO39613 www.roche.com/about_roche/roche_worldwide.htm

Phone: 888-662-6728 (U.S. Only)

Email: global-roche-genentech-trials@gene.com

Locations

Facility Status Contact
UCLA Department of Medicine
Los Angeles, California 90024
United States
Recruiting
UCSF Comprehensive Cancer Ctr
San Francisco, California 94158
United States
Not yet recruiting
Stanford Cancer Center
Stanford, California 94305-5820
United States
Not yet recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Recruiting
Centre Francois Baclesse; Pharmacie
Caen, 14076
France
Not yet recruiting
Centre Leon Berard
Lyon, 69008
France
Recruiting
Institut régional du Cancer Montpellier
Montpellier, 34298
France
Recruiting
Institut Claudius Regaud; Radiotherapie
Toulouse, 31052
France
Recruiting
Gustave Roussy Cancer Campus
Villejuif, 94805
France
Not yet recruiting
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28
Greece
Active, not recruiting
Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine
Athens, 12462
Greece
Not yet recruiting
University Hospital of Patras Medical Oncology
Patras, 265 04
Greece
Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Recruiting
Asan Medical Center - Oncology
Seoul, 05505
Korea, Republic of
Recruiting
Severance Hospital; Yonsei Cancer Center; Yonsei University College of Medicine
Seoul, 120-749
Korea, Republic of
Recruiting
ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarra 31008
Spain
Recruiting
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Spain
Recruiting
Hospital General Universitario Gregorio Mara
Madrid, 28009
Spain
Recruiting
MD Anderson Cancer Center
Madrid, 28033
Spain
Recruiting
Hospital Univ 12 de Octubre
Madrid, 28041
Spain
Recruiting
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
Spain
Recruiting
Barts and The London
London, EC1M 6BQ
United Kingdom
Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Withdrawn
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
United Kingdom
Recruiting