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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04300647
Other study ID # WO42017
Secondary ID 2019-004895-21
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2020
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 172
Est. completion date December 30, 2024
Est. primary completion date December 8, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Australia Mater Misericordiae Limited South Brisbane Queensland
Brazil Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania GO
Brazil Hospital de Caridade de Ijui; Oncologia Ijui RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital Sao Rafael - HSR Salvador BA
Brazil Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Sao Paulo SP
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario
Canada London Regional Cancer Centre London Ontario
Canada Jewish General Hospital Montreal Quebec
Canada McGill University Health Centre - Glen Site Montreal Quebec
Canada Princess Margaret Cancer Center Toronto Ontario
Costa Rica Clinica CIMCA San José
Costa Rica ICIMED Instituto de Investigación en Ciencias Médicas San José
Costa Rica Oncotech S.A. San José
France 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
Italy IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna
Italy IRCCS S. Raffaele; Ginecologia Oncologica Milano Lombardia
Italy Istituto Europeo Di Oncologia Milano Lombardia
Italy Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica Napoli Campania
Italy Policlinico Universitario Agostino Gemelli Roma Lazio
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Mexico Christus Muguerza Clinica Vidriera Monterrey Nuevo LEON
Panama Centro Oncológico de Panamá Panama
Panama The Panama Clinic Panama
Peru Clinica Ricardo Palma San Isidro
Poland Bialostockie Centrum Onkologi Bialystok
Poland Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny Gdynia
Poland Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter. Gliwice
Poland Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie Poznan
Poland Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej Warszawa
Russian Federation Chelyabisnk regional clinical center for oncology and nuclear medicine Chelyabinsk Sverdlovsk
Russian Federation Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Kazan Tatarstan
Russian Federation FSBI "National Medical Research Center of Oncology N.N. Blokhin? Moscow Moskovskaja Oblast
Russian Federation MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy Moscow Moskovskaja Oblast
Russian Federation Murmansk Regional Clinical Hospital named after P.A. Bayandin Murmansk
Russian Federation Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological Tomsk
Russian Federation Volgograd Regional Clinical Oncology Dispensary Volgograd
Spain Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia A Coruña LA Coruña
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Taiwan Taichung Veterans General Hospital; Obstetrics and Gynecology Taichung
Taiwan Mackay Memorial Hospital; Obstetrics & Gynaecology Taipei City
Taiwan National Taiwan University Hospital; Obstetrics & Gynecology Taipei City
Taiwan Taipei Veterans General Hospital Taipei City
Taiwan Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology Taoyuan City
Thailand Siriraj Hospital, Mahidol University Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University Muang
United Kingdom Sarah Cannon Research Institute London
United Kingdom University College London Hospital London
United Kingdom Christie Hospital Nhs Trust; Medical Oncology Manchester
United States Augusta University Augusta Georgia
United States Oncology Associates of Oregon, P.C Eugene Oregon
United States Kaiser Permanente - Irvine Irvine California
United States Arizona Oncology Associates Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Costa Rica,  France,  Italy,  Korea, Republic of,  Mexico,  Panama,  Peru,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) From randomization up to approximately 36 months
Secondary Percentage of Participants With Adverse Events Up to 36 months
Secondary IRC-Assessed Duration of Response (DOR) First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary IRC-Assessed Disease Control Rate (DCR) From randomization up to approximately 36 months
Secondary Investigator-Assessed Best Clinical Response (BCR) Rate From randomization up to approximately 36 months
Secondary Investigator-Assessed DOR First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary IRC-Assessed Progression-Free Survival (PFS) From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary IRC-Assessed PFS Rate at 6 Months At 6 months post-randomization
Secondary Overall Survival (OS) From randomization to death from any cause (up to 36 months)
Secondary OS Rate at 6 Months and 12 Months At 6 and 12 months post-randomization
Secondary Minimum Serum Concentration (Cmin) of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months)
Secondary Maximum Serum Concentration (Cmax) of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Secondary Cmin of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Secondary Cmax of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Secondary Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
Secondary Percentage of Participants With ADAs to Atezolizumab Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
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