A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

Last updated: June 11, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Digestive System Neoplasms

Gall Bladder Cancer

Biliary Tract Cancer

Treatment

Placebo

Bevacizumab

Gemcitabine

Clinical Study ID

NCT04677504
GO42661
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Considered to be eligible to receive platinum-based chemotherapy, in theinvestigator's judgment

  • Documentation of recurrent/metastatic or locally advanced unresectable disease basedon computed tomography (CT) or magnetic resonance imaging (MRI) scans

  • Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC

  • No prior systemic therapy for advanced BTC

  • At least one measurable untreated lesion (per RECIST v1.1)

  • Adequate biliary drainage with no evidence of ongoing infection

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

  • Life expectancy of > 3 months

  • Adequate hematologic and end-organ function

  • For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods, and agreement to refrainfrom donating eggs

  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) oruse a condom, and agreement to refrain from donating sperm

Exclusion

Exclusion Criteria:

  • Recurrent disease <=6 months after curative surgery or <= 6 months after thecompletion of adjuvant therapy

  • Prior local regional therapy such as radioembolization

  • Combined or mixed hepatocellular/cholangiocarcinoma

  • Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 ofCycle 1

  • National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade >= 2peripheral neuropathy

  • Prior bleeding event due to untreated or incompletely treated esophageal and/orgastric varices within 6 months prior to Day 1 of Cycle 1

  • Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 5 months after the final dose of atezolizumab or within 6 months after thefinal dose of bevacizumab, cisplatin or gemcitabine

  • Active or history of autoimmune disease or immune deficiency

  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis onscreening chest computed tomography scan

  • History of malignancy other than BTC within 5 years prior to screening, with theexception of malignancies with a negligible risk of metastasis or death

  • Symptomatic, untreated, or actively progressing CNS metastases

  • For patients with lung metastases, if one of the following criteria applies: Large,centrally located pulmonary metastases; Clear tumor infiltration into the thoracicgreat vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging

  • Active tuberculosis

  • Co-infection with HBV and HCV

  • Treatment with systemic immunostimulatory agents or immunosuppressive medication

  • Inadequately controlled arterial hypertension

  • History of hypertensive crisis or hypertensive encephalopathy

  • Significant vascular disease

  • Evidence of bleeding diathesis or significant coagulopathy

  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture

  • Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

  • Preexisting renal impairment, myelosuppression, or hearing impairment

Study Design

Total Participants: 162
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 23, 2021
Estimated Completion Date:
August 25, 2023

Connect with a study center

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Sunnybrook Odette Cancer Centre; Clinical Trials

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Centre Universitaire de sante de l'Estrie (CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Beijing Union Hospital

    Beijing, 100730
    China

    Site Not Available

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou City, 310016
    China

    Site Not Available

  • Harbin Medical University Tumor Hospital

    Harbin City, 150081
    China

    Site Not Available

  • Nan Tong Tumor Hospital

    Nantong,
    China

    Site Not Available

  • Nan Tong Tumor Hospital

    Nantong City, 226361
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Chu La Miletrie; Gastro Enterologie Endoscopies

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Saint-Etienne - Hopital Nord

    Saint Etienne, 42055
    France

    Site Not Available

  • Institut Gustave Roussy; Gastro-Enterologie

    Villejuif, 94805
    France

    Site Not Available

  • Queen Mary Hospital; Dept. Of Haematology & Oncology

    Hong Kong,
    Hong Kong

    Site Not Available

  • Prince of Wales Hosp; Dept. Of Clinical Onc

    Shatin,
    Hong Kong

    Site Not Available

  • Fondazione Pascale; U.O. Sperimentazioni Cliniche

    Napoli, Campania 80100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"

    Bologna, Emilia-Romagna 40139
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Gerardo; Gastroenterologia

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • Istituto Clinico Humanitas - Humanitas Cancer Center

    Rozzano, Sicilia 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana; Unita Operativa Medica

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

    Padova, Veneto 35128
    Italy

    Site Not Available

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

    Bytom, 41-902
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

    Gdansk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii

    Koszalin, 75-581
    Poland

    Site Not Available

  • NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii

    Warszawa, 02-034
    Poland

    Site Not Available

  • Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

    Wroc?aw, 53-413
    Poland

    Site Not Available

  • Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

    Wrocław, 53-413
    Poland

    Site Not Available

  • FSBI "National Medical Research Center of Oncology N.N. Blokhin?

    Moscow, Moskovskaja Oblast 115478
    Russian Federation

    Site Not Available

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, Moskovskaja Oblast 119991
    Russian Federation

    Site Not Available

  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

    Moskva, Moskovskaja Oblast 111123
    Russian Federation

    Site Not Available

  • Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency

    Nizhny Novgorod, Niznij Novgorod 603109
    Russian Federation

    Site Not Available

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, Sankt Petersburg 197758
    Russian Federation

    Site Not Available

  • Hospital General Universitario de Elche; Servicio de Oncologia

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra; Servicio de Oncologia

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron; Oncology

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034
    Spain

    Site Not Available

  • Complejo Hospitalario de Orense; Servicio de Oncologia

    Orense, 32005
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009
    Spain

    Site Not Available

  • National Taiwan Uni Hospital; Dept of Oncology

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital; Department of Oncology

    Taipei City, 112201
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital-Linkou; Dept of Oncology

    Taoyuan County, 333
    Taiwan

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hosp; Oncology Unit

    Chiangmai, 50200
    Thailand

    Site Not Available

  • Srinagarind Hospital; Medical Oncology Unit

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Sunpasitthiprasong Hospital; Oncology and/or Hematology

    Ubon Ratchathani, 34000
    Thailand

    Site Not Available

  • Adana Ac?badem Hospital Oncology Department

    Adana, 01130
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300
    Turkey

    Site Not Available

  • Ege Uni Medical Faculty Hospital; Oncology Dept

    Izmir, 35100
    Turkey

    Site Not Available

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280
    Turkey

    Site Not Available

  • Koc Universitesi Hastanesi; T?bbi Onkoloji

    Zeyt?nburnu, 34010
    Turkey

    Site Not Available

  • Koc Universitesi Hastanesi; Tıbbi Onkoloji

    Zeyti̇nburnu, 34010
    Turkey

    Site Not Available

  • SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine

    Kyiv, KIEV Governorate 03126
    Ukraine

    Site Not Available

  • ?Kharkov Regional Oncology Center

    Kharkiv, Kharkiv Governorate 61070
    Ukraine

    Site Not Available

  • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

    Kharkiv, Kharkiv Governorate 61018
    Ukraine

    Site Not Available

  • Bristol Royal Infirmary

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QS
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, OX3 7LJ
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Newport Beach UC Irvine Medical Center

    Costa Mesa, California 92627
    United States

    Site Not Available

  • City of Hope Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • California Pacific Med Center

    San Francisco, California 94115
    United States

    Site Not Available

  • City of Hope-South Pasadena

    South Pasadena, California 91030
    United States

    Site Not Available

  • City of Hope; Upland

    Upland, California 91786
    United States

    Site Not Available

  • MedStar Washington Hosp Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • SCRI-Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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