Clinical trial NCT04300647: A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-03-09
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 17 months
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Up to 36 months
measure: IRC-Assessed Duration of Response (DOR)
timeFrame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)
measure: IRC-Assessed Disease Control Rate (DCR)
timeFrame: From randomization up to approximately 17 months
measure: Investigator-Assessed Best Clinical Response (BCR) Rate
timeFrame: From randomization up to approximately 17 months
measure: Investigator-Assessed Duration of BCR
timeFrame: First occurrence of a documented clinical response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)
measure: IRC-Assessed Progression-Free Survival (PFS)
timeFrame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)
measure: IRC-Assessed PFS Rate at 6 Months
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: From randomization to death from any cause (up to approximately 17 months)
measure: OS Rate at 6 Months and 12 Months
timeFrame: 6 months, 12 months
Other outcomes:
measure: Minimum Serum Concentration (Cmin) of Tiragolumab
timeFrame: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16
measure: Maximum Serum Concentration (Cmax) of Tiragolumab
timeFrame: Cycle 1 Day 1 at 30 minutes post-dose
measure: Cmin of Atezolizumab
timeFrame: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16
measure: Cmax of Atezolizumab
timeFrame: Day 1 of Cycle 1 at 30 minutes post-dose
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
timeFrame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16
measure: Percentage of Participants With ADAs to Atezolizumab
timeFrame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Irvine
country: United States
facility: Kaiser Permanente - Irvine
state: California
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C
state: Oregon
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: Bahia
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: São Paulo
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Villejuif CEDEX
country: France
facility: Gustave Roussy
city: Napoli
country: Italy
facility: Istituto Tumori Napoli
state: Campania
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera
state: Nuevo LEON
city: Panama
country: Panama
facility: Centro Oncológico de Panamá
city: Panama
country: Panama
facility: The Panama Clinic
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: Gdynia
country: Poland
facility: Szpital Morski im.PCK
city: Gliwice
country: Poland
facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
city: Moscow
country: Russian Federation
facility: MEDSI Clinical Hospital on Pyatnitsky Highway
state: Moskovskaja Oblast
city: Chelyabinsk
country: Russian Federation
facility: Chelyabisnk regional clinical center for oncology and nuclear medicine
state: Sverdlovsk
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
state: Tatarstan
city: Tomsk
country: Russian Federation
facility: Tomsk scientific research institute of oncology SO RAMN, PAD
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: La Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: