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NCT04300647CompletedPhase 2

A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
172 (actual)
First submitted
6 Mar 2020
Start date
30 Jun 2020
Primary completion date
8 Dec 2021
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04300647
EudraCT number
2019-004895-21

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 172
  • From 30 Jun 2020 to the primary completion date, 8 Dec 2021
  • 58 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
  • 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

Other illness

  • 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
  • Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations

Other

  • Active or untreated central nervous system (CNS) or brain metastases
  • Pregnant or breastfeeding woman

Who the study is looking for

  • Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mater Misericordiae Limited
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South BrisbaneAustraliaUnknown status
Hospital Araújo Jorge
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GoiâniaBrazilUnknown status
Hospital de Caridade de Ijui
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IjuíBrazilUnknown status
Hospital Nossa Senhora da Conceição
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilUnknown status
Hospital Sao Rafael - HSR
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SalvadorBrazilUnknown status
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
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São PauloBrazilUnknown status
Royal Victoria Regional Health Centre
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BarrieCanadaUnknown status
London Regional Cancer Centre
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LondonCanadaUnknown status
McGill University Health Centre Glen Site
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MontrealCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Princess Margaret Cancer Center
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TorontoCanadaUnknown status
ICIMED Instituto de Investigación en Ciencias Médicas
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San JoséCosta RicaUnknown status
Clinica CIMCA
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San JoséCosta RicaUnknown status
Complejo Hospitalario Universitario A Coruña (CHUAC)
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A CoruñaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Institut Paoli-Calmettes
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MarseilleFranceUnknown status
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
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MontpellierFranceUnknown status
ICO - Site René Gauducheau
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Saint-HerblainFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status
Sarah Cannon Research Institute
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LondonUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
Istituto Europeo di Oncologia
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MilanItalyUnknown status
Istituto Tumori Napoli
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NaplesItalyUnknown status
Policlinico Universitario Agostino Gemelli
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RomeItalyUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Christus Muguerza Clinica Vidriera
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MonterreyMexicoUnknown status
Centro Oncológico de Panamá
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Panama CityPanamaUnknown status
The Panama Clinic
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Panama CityPanamaUnknown status
Clinica Ricardo Palma
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San IsidroPeruUnknown status
Bialostockie Centrum Onkologi
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BialystokPolandUnknown status
Szpital Morski im.PCK
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GdyniaPolandUnknown status
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice
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GliwicePolandUnknown status
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
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PoznanPolandUnknown status
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
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WarsawPolandUnknown status
Chelyabisnk regional clinical center for oncology and nuclear medicine
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ChelyabinskRussiaUnknown status
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
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Kazan'RussiaUnknown status
MEDSI Clinical Hospital on Pyatnitsky Highway
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MoscowRussiaUnknown status
Tomsk scientific research institute of oncology SO RAMN, PAD
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TomskRussiaUnknown status
Volgograd Regional Clinical Oncology Dispensary
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VolgogradRussiaUnknown status
Maharaj Nakorn Chiang Mai Hospital
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MuangThailandUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation Linkou Branch
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Taoyuan CityTaiwanUnknown status
Augusta University
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AugustaUnited StatesUnknown status
Oncology Associates of Oregon, P.C.
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EugeneUnited StatesUnknown status
Kaiser Permanente-Irvine
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IrvineUnited StatesUnknown status
Arizona Oncology Associates
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PhoenixUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.