A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
- Conditions
- Cervical Cancer
- Interventions
- Registration Number
- NCT04300647
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 172
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab Atezolizumab Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Tiragolumab plus Atezolizumab Tiragolumab Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Tiragolumab plus Atezolizumab Atezolizumab Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- Primary Outcome Measures
Name Time Method Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) From randomization up to approximately 36 months
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Up to 36 months IRC-Assessed Disease Control Rate (DCR) From randomization up to approximately 36 months 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) 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) 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) Investigator-Assessed Best Clinical Response (BCR) Rate From randomization up to approximately 36 months 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) IRC-Assessed PFS Rate at 6 Months At 6 months post-randomization Overall Survival (OS) From randomization to death from any cause (up to 36 months) OS Rate at 6 Months and 12 Months At 6 and 12 months post-randomization 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) 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) 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) 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) 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)
Trial Locations
- Locations (66)
Kaiser Permanente - Irvine
🇺🇸Irvine, California, United States
Oncology Associates of Oregon, P.C
🇺🇸Eugene, Oregon, United States
Mater Misericordiae Limited
🇦🇺South Brisbane, Queensland, Australia
Augusta University
🇺🇸Augusta, Georgia, United States
Hospital Sao Rafael - HSR
🇧🇷Salvador, BA, Brazil
Hospital de Caridade de Ijui; Oncologia
🇧🇷Ijui, RS, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
🇧🇷Goiania, GO, Brazil
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
🇧🇷Sao Paulo, SP, Brazil
Hamilton Health Sciences - Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Princess Margaret Cancer Center
🇨🇦Toronto, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
🇨🇦Montreal, Quebec, Canada
Centre Leon Berard
🇫🇷Lyon, France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
🇫🇷Montpellier, France
ICO - Site René Gauducheau
🇫🇷Saint Herblain, France
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
🇮🇹Napoli, Campania, Italy
Gustave Roussy
🇫🇷Villejuif, France
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Lazio, Italy
IRCCS S. Raffaele; Ginecologia Oncologica
🇮🇹Milano, Lombardia, Italy
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Christus Muguerza Clinica Vidriera
🇲🇽Monterrey, Nuevo LEON, Mexico
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Clinica Ricardo Palma
🇵🇪San Isidro, Peru
The Panama Clinic
🇵🇦Panama, Panama
Bialostockie Centrum Onkologi
🇵🇱Bialystok, Poland
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
🇵🇱Poznan, Poland
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
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
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
🇪🇸A Coruña, LA Coruña, Spain
Taichung Veterans General Hospital; Obstetrics and Gynecology
🇨🇳Taichung, Taiwan
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
National Taiwan University Hospital; Obstetrics & Gynecology
🇨🇳Taipei City, Taiwan
Siriraj Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand
University College London Hospital
🇬🇧London, United Kingdom
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
🇬🇧Manchester, United Kingdom
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
🇵🇱Warszawa, Poland
Mackay Memorial Hospital; Obstetrics & Gynaecology
🇨🇳Taipei City, Taiwan
Clinica CIMCA
🇨🇷San José, Costa Rica
Centro Oncológico de Panamá
🇵🇦Panama, Panama
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
🇵🇱Gliwice, Poland
Volgograd Regional Clinical Oncology Dispensary
🇷🇺Volgograd, Russian Federation
Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology
🇨🇳Taoyuan City, Taiwan
Oncotech S.A.
🇨🇷San José, Costa Rica
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
🇵🇱Gdynia, Poland
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
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
ICIMED Instituto de Investigación en Ciencias Médicas
🇨🇷San José, Costa Rica
Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University
🇹ðŸ‡Muang, Thailand
Institut Paoli Calmettes
🇫🇷Marseille, France
Arizona Oncology Associates
🇺🇸Phoenix, Arizona, United States