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 Outcome 1 - Measure: Objective Response Rate (ORR)
Primary Outcome 1 - Time Frame: Baseline until disease progression or loss of clinical benefit (approximately 4 years)
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
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
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 |