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Brief Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

INTRODUCTION

  • Org Study ID: BO42843
  • Secondary ID: N/A
  • NTC ID: NCT04660344
  • Sponsor: Hoffmann-La Roche

BRIEF SUMMARY

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

  • Overall Status
    Recruiting
  • Start Date
    May 3, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: IRF-assessed DFS in Participants Who Are ctDNA Positive Within 20 Weeks of Cystectomy

Primary Outcome 1 - Timeframe: Randomization up to first occurrence of DFS event (up to approximately 73 months)

CONDITION

  • Muscle-invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria for the Surveillance Phase:
Histologically confirmed MIUC (also termed TCC) of the bladder

- TNM classification (based on AJCC Cancer Staging Manual, 7th Edition; Edge et al. 2010) at pathological examination of surgical resection specimen as follows: For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0. For patients who have not received prior NAC: tumor stage of pT3-4a or pN+ and M0

- Surgical resection of MIUC of the bladder

- Patients who have not received prior platinum-based NAC, have refused, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy

- ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood.

- Tumor PD-L1 expression per IHC and confirmed diagnosis of MIUC as documented through central testing of a representative tumor tissue specimen

- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment.

- Full recovery from cystectomy and enrollment within 14 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery.
Additional Inclusion Criteria for the Treatment Phase:
Plasma sample evaluated to be ctDNA positive

- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization.

- ECOG Performance Status of <= 2 - Life expectancy >=12 weeks

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
General Medical Exclusion Criteria:
Pregnancy or breastfeeding

- 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. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

- Positive test for HIV

- Patients with active hepatitis B virus or hepatitis C

- Active tuberculosis

- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
Cancer-Specific Exclusion Criteria:
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment

- Adjuvant chemotherapy or radiation therapy for UC following cystectomy

- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment

- Malignancies other than UC within 5 years prior to study enrollment
Additional Exclusion Criteria for the Treatment Phase:
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase Hormone-replacement therapy or oral contraceptives are allowed.

- Adjuvant chemotherapy or radiation therapy for UC following cystectomy

- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization to the treatment phase

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 888-662-6728 (U.S. and Canada)

Email: global.rochegenentechtrials@roche.com

LOCATION

Facility Status Contact
Facility: Sansum Clinic
Santa Barbara, California 93105
United States
Status: Recruiting Contact: N/A
Facility: Rocky Mountain Cancer Center - Denver
Littleton, Colorado 80120
United States
Status: Recruiting Contact: N/A
Facility: Woodlands Medical Specialists, P.A.
Pensacola, Florida 32503
United States
Status: Recruiting Contact: N/A
Facility: Cancer Care Centers of Brevard
Rockledge, Florida 32955
United States
Status: Recruiting Contact: N/A
Facility: Optum Health Care
Las Vegas, Nevada 89106
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology Cancer Center
Austin, Texas 78731
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Medical City Dallas
Dallas, Texas 75230
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Denton South
Denton, Texas 76201
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology - Houston (Gessner)
Houston, Texas 77024
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology - Willowbrook
Houston, Texas 77070
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology P.A. (McKinney)
McKinney, Texas 75071
United States
Status: Recruiting Contact: N/A
Facility: Centro Medico Austral
Buenos Aires, CE 1019
Argentina
Status: Recruiting Contact: N/A
Facility: AZ KLINA
Brasschaat, PR 2930
Belgium
Status: Recruiting Contact: N/A
Facility: UZ Gent
Gent, RS 9000
Belgium
Status: Recruiting Contact: N/A
Facility: AZ Delta (Campus Rumbeke)
Roeselare, RS 8800
Belgium
Status: Recruiting Contact: N/A
Facility: Hospital Nossa Senhora da Conceicao
Porto Alegre, SP 91350-200
Brazil
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00
Czechia
Status: Recruiting Contact: N/A
Facility: Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN
Praha 4 - Krc, 140 59
Czechia
Status: Recruiting Contact: N/A
Facility: Institut Sainte Catherine;Recherche Clinique
Avignon, 84918
France
Status: Recruiting Contact: N/A
Facility: Hopital Saint Andre
Bordeaux, 33075
France
Status: Recruiting Contact: N/A
Facility: Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100
France
Status: Recruiting Contact: N/A
Facility: Centre Antoine Lacassagne
Nice, 06189
France
Status: Recruiting Contact: N/A
Facility: Institut Mutualiste Montsouris; Oncologie
Paris, 75674
France
Status: Recruiting Contact: N/A
Facility: Hopital Foch; Oncologie
Suresnes, 92151
France
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
Herne, 44625
Germany
Status: Recruiting Contact: N/A
Facility: St Vincents University Hospital
Dublin, 9112000
Ireland
Status: Recruiting Contact: N/A
Facility: Rambam Medical Center; Oncology
Haifa, 4941492
Israel
Status: Recruiting Contact: N/A
Facility: Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 6423906
Israel
Status: Recruiting Contact: N/A
Facility: Rabin Medical Center; Oncology Dept
Petach Tikva, 80131
Israel
Status: Recruiting Contact: N/A
Facility: Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 80131
Israel
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
Napoli, 40138
Italy
Status: Recruiting Contact: N/A
Facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, 47014
Italy
Status: Recruiting Contact: N/A
Facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
Bologna, 00168
Italy
Status: Recruiting Contact: N/A
Facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, 16132
Italy
Status: Recruiting Contact: N/A
Facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, 20089
Italy
Status: Recruiting Contact: N/A
Facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, 35128
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Santa Maria di Terni
Terni, 466-8560
Italy
Status: Recruiting Contact: N/A
Facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, 260-8717
Italy
Status: Recruiting Contact: N/A
Facility: Chiba Cancer Center
Chiba, 812-8582
Japan
Status: Recruiting Contact: N/A
Facility: Shikoku Cancer Center
Ehime, 730-8518
Japan
Status: Recruiting Contact: N/A
Facility: Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 305-8576
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organization Hokkaido Cancer Center
Hokkaido, 028-3695
Japan
Status: Recruiting Contact: N/A
Facility: University of Tsukuba Hospital
Ibaraki, 216-8511
Japan
Status: Recruiting Contact: N/A
Facility: Iwate Medical University Hospital
Iwate, 606-8507
Japan
Status: Recruiting Contact: N/A
Facility: St. Marianna University School of Medicine Hospital
Kanagawa, 700-8558
Japan
Status: Recruiting Contact: N/A
Facility: Kyoto University Hospital
Kyoto, 541-8567
Japan
Status: Recruiting Contact: N/A
Facility: Okayama University Hospital
Okayama, 565-0871
Japan
Status: Recruiting Contact: N/A
Facility: Osaka International Cancer Institute
Osaka, 350-1298
Japan
Status: Recruiting Contact: N/A
Facility: Osaka University Hospital
Osaka, 362-0806
Japan
Status: Recruiting Contact: N/A
Facility: Saitama Medical University International Medical Center
Saitama, 411-8777
Japan
Status: Recruiting Contact: N/A
Facility: Saitama Cancer Center
Saitama, 770-8503
Japan
Status: Recruiting Contact: N/A
Facility: Shizuoka Cancer Center
Shizuoka, 104-0045
Japan
Status: Recruiting Contact: N/A
Facility: Tokushima University Hospital
Tokushima, 135-8550
Japan
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital
Tokyo, 160-8582
Japan
Status: Recruiting Contact: N/A
Facility: The Cancer Institute Hospital of JFCR
Tokyo, 41404
Japan
Status: Recruiting Contact: N/A
Facility: Keio University Hospital
Tokyo, 10408
Japan
Status: Recruiting Contact: N/A
Facility: Kyungpook National University Chilgok Hospital
Daegu, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, 05505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, 36-200
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 85-094
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, 30-510
Poland
Status: Recruiting Contact: N/A
Facility: PRATIA MCM Kraków
Kraków, 04-073
Poland
Status: Recruiting Contact: N/A
Facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
Poznań, 53-413
Poland
Status: Recruiting Contact: N/A
Facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Warszawa, 93-513
Poland
Status: Recruiting Contact: N/A
Facility: Dolnoslaskie Centrum Onkologii
Wrocław, 249036
Poland
Status: Recruiting Contact: N/A
Facility: FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
Obninsk, 188663
Russian Federation
Status: Recruiting Contact: N/A
Facility: Ivanovo Regional Oncology Dispensary
Ivanovo, 115478
Russian Federation
Status: Recruiting Contact: N/A
Facility: St-Petersburg Regional Oncology Dispensary; Oncology
Kuzmolovo, 117997
Russian Federation
Status: Recruiting Contact: N/A
Facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin
Murmansk, 197758
Russian Federation
Status: Recruiting Contact: N/A
Facility: Privolzhsk Regional Medical Center
Nizhny Novgorod, 8208
Russian Federation
Status: Recruiting Contact: N/A
Facility: FSI Russian Centre of Radiology and Surgical Technologies
Saint-Petersburg, 14004
Russian Federation
Status: Recruiting Contact: N/A
Facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, 20080
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08041
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, 28007
Spain
Status: Recruiting Contact: N/A
Facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 28033
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, 01250
Spain
Status: Recruiting Contact: N/A
Facility: Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 06700
Spain
Status: Recruiting Contact: N/A
Facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, 79010
Ukraine
Status: Recruiting Contact: N/A
Facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, BT9 7AB
Ukraine
Status: Recruiting Contact: N/A
Facility: Kyiv City Clinical Oncological Center
Kyiv, CB2 0QQ
Ukraine
Status: Recruiting Contact: N/A
Facility: Western General Hospital
Edinburgh, EC1M 6BQ
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Marsden Hospital (Sutton)
Sutton,
United Kingdom
Status: Recruiting Contact: N/A