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
- Diseases
- Cervical cancer
- 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
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Misericordiae Limited Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Hospital Araújo Jorge Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Hospital de Caridade de Ijui Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceição Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Lucas - PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Rafael - HSR Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| London Regional Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Centre Glen Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| ICIMED Instituto de Investigación en Ciencias Médicas Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Clinica CIMCA Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Complejo Hospitalario Universitario A Coruña (CHUAC) Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| ICO - Site René Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Tumori Napoli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Christus Muguerza Clinica Vidriera Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Centro Oncológico de Panamá Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
| The Panama Clinic Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
| Clinica Ricardo Palma Coordinator of this site? Confirm its status | San Isidro | Peru | Unknown status |
| Bialostockie Centrum Onkologi Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Szpital Morski im.PCK Coordinator of this site? Confirm its status | Gdynia | Poland | Unknown status |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice Coordinator of this site? Confirm its status | Gliwice | Poland | Unknown status |
| Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Chelyabisnk regional clinical center for oncology and nuclear medicine Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| MEDSI Clinical Hospital on Pyatnitsky Highway Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Tomsk scientific research institute of oncology SO RAMN, PAD Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| Volgograd Regional Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Volgograd | Russia | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Muang | Thailand | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation Linkou Branch Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Oncology Associates of Oregon, P.C. Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Kaiser Permanente-Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Arizona Oncology Associates Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.