A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
NCT ID: NCT04300647
Last Updated: 2025-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2020-06-30
2025-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tiragolumab plus Atezolizumab
Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Atezolizumab
Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Interventions
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Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiologically-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
* Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
* Life expectancy of at least 12 weeks
* Adequate hematologic and organ function
* Female of childbearing potential must be willing to comply with adequate contraception
Exclusion Criteria
* Active or untreated central nervous system (CNS) or brain metastases
* Active or history of autoimmune disease or immune deficiency
* Active tuberculosis
* Known, clinically significant liver disease
* Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
* Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
* Pregnant or breastfeeding woman
* Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Oncology Associates
Phoenix, Arizona, United States
Kaiser Permanente - Irvine
Irvine, California, United States
Augusta University
Augusta, Georgia, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, United States
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Clinica CIMCA
San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
Montpellier, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Istituto Tumori Napoli
Napoli, Campania, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León, Mexico
Centro Oncológico de Panamá
Panama City, , Panama
The Panama Clinic
Panama City, , Panama
Clinica Ricardo Palma
San Isidro, , Peru
Szpital Morski im.PCK
Gdynia, , Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice
Gliwice, , Poland
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
Poznan, , Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, , Poland
MEDSI Clinical Hospital on Pyatnitsky Highway
Moscow, Moscow Oblast, Russia
Chelyabisnk regional clinical center for oncology and nuclear medicine
Chelyabinsk, Sverdlovsk Oblast, Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', Tatarstan Republic, Russia
Tomsk scientific research institute of oncology SO RAMN, PAD
Tomsk, , Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, , Russia
Keimyung University Dongsan Hospital
Daegu, , South Korea
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation, Linkou Branch
Taoyuan, , Taiwan
Maharaj Nakorn Chiang Mai Hospital
Muang, , Thailand
University College London Hospital
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Countries
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References
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Salani R, McCormack M, Kim YM, Ghamande S, Hall SL, Lorusso D, Barraclough L, Gilbert L, Guzman Ramirez A, Lu CH, Sabatier R, Colombo N, Hu Y, Krishnan V, Molinero L, Feng Y, Kim N, Castro M, Lin YG, Monk BJ. A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04). Int J Gynecol Cancer. 2024 Aug 5;34(8):1140-1148. doi: 10.1136/ijgc-2024-005588.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-004895-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO42017
Identifier Type: -
Identifier Source: org_study_id
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