A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | October 5, 2015 |
End Date: | May 10, 2022 |
A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and
safety of adjuvant treatment with atezolizumab compared with observation in participants with
muscle-invasive UC who are at high risk for recurrence following resection. Eligible
participants will be randomized by a 1:1 ratio into atezolizumab group or control group.
safety of adjuvant treatment with atezolizumab compared with observation in participants with
muscle-invasive UC who are at high risk for recurrence following resection. Eligible
participants will be randomized by a 1:1 ratio into atezolizumab group or control group.
Inclusion Criteria:
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma)
of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
- For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a
or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
- For participants who have not received prior neoadjuvant chemotherapy: tumor stage of
pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
- Representative formalin-fixed paraffin-embedded tumor specimens from surgical
resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in
paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated
pathology report, for central testing and determined to be evaluable for tumor
programmed death-ligand 1 (PD-L1) expression prior to study enrollment
- Absence of residual disease and absence of metastasis, as confirmed by a negative
baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis,
abdomen, and chest no more than 4 weeks prior to randomization
- Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
- Eastern Cooperative Oncology Group performance status of less than or equal to (=) 2
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and end-organ function
- For women who are not postmenopausal or surgically sterile: agreement to remain
abstinent or use contraceptive methods that result in a failure rate of less than (<)
1 percent (%) per year during the treatment period and for at least 5 months after the
last dose of atezolizumab
Exclusion Criteria:
- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Adjuvant chemotherapy or radiation therapy for UC following surgical resection
- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days or five half-lives of the drug prior to
enrollment
- Malignancies other than UC within 5 years prior to Cycle 1, Day 1
- Pregnancy or breastfeeding
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to Cycle 1, Day 1
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day
1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
or any component of the atezolizumab formulation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplant
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan
- Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis
C or tuberculosis
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-CD40, anti-cytotoxic
T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1),
and anti-PD-L1 therapeutic antibodies
We found this trial at
60
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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University of Miami Hospital The University of Miami changed the face of modern health care...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Redondo Beach, California 90277
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715 Tank Farm Road
San Luis Obispo, California 93401
San Luis Obispo, California 93401
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10460 North 92nd Street
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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