Back to resultsA Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer (SKYSCRAPER-04)
Primary Purpose
Cervical Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tiragolumab
Atezolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
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
Sites / Locations
- Arizona Oncology Associates
- Kaiser Permanente - Irvine
- Augusta University
- Oncology Associates of Oregon, P.C
- Mater Misericordiae Limited
- Hospital Sao Rafael - HSR
- Hospital Araujo Jorge; Departamento de Ginecologia E Mama
- Hospital de Caridade de Ijui; Oncologia
- Hospital Sao Lucas - PUCRS
- Hospital Nossa Senhora da Conceicao
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
- Royal Victoria Regional Health Centre
- Hamilton Health Sciences - Juravinski Cancer Centre
- London Regional Cancer Centre
- Princess Margaret Cancer Center
- Jewish General Hospital
- McGill University Health Centre - Glen Site
- Clinica CIMCA
- Oncotech S.A.
- ICIMED Instituto de Investigación en Ciencias Médicas
- Centre Leon Berard
- Institut Paoli Calmettes
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
- ICO - Site René Gauducheau
- Gustave Roussy
- Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
- Policlinico Universitario Agostino Gemelli
- IRCCS S. Raffaele; Ginecologia Oncologica
- Istituto Europeo Di Oncologia
- Keimyung University Dongsan Hospital
- Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital
- Samsung Medical Center
- Christus Muguerza Clinica Vidriera
- Centro Oncológico de Panamá
- The Panama Clinic
- Clinica Ricardo Palma
- Bialostockie Centrum Onkologi
- Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
- Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
- Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
- FSBI "National Medical Research Center of Oncology N.N. Blokhin?
- MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
- Chelyabisnk regional clinical center for oncology and nuclear medicine
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
- Murmansk Regional Clinical Hospital named after P.A. Bayandin
- Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
- Volgograd Regional Clinical Oncology Dispensary
- Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital Universitario La Paz; Servicio de Oncologia
- Taichung Veterans General Hospital; Obstetrics and Gynecology
- National Taiwan University Hospital; Obstetrics & Gynecology
- Taipei Veterans General Hospital
- Mackay Memorial Hospital; Obstetrics & Gynaecology
- Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology
- Siriraj Hospital, Mahidol University
- Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University
- University College London Hospital
- Sarah Cannon Research Institute
- Christie Hospital Nhs Trust; Medical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tiragolumab plus Atezolizumab
Atezolizumab
Arm Description
Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Outcomes
Primary Outcome Measures
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Secondary Outcome Measures
Percentage of Participants With Adverse Events
IRC-Assessed Duration of Response (DOR)
IRC-Assessed Disease Control Rate (DCR)
Investigator-Assessed Best Clinical Response (BCR) Rate
Investigator-Assessed DOR
IRC-Assessed Progression-Free Survival (PFS)
IRC-Assessed PFS Rate at 6 Months
Overall Survival (OS)
OS Rate at 6 Months and 12 Months
Minimum Serum Concentration (Cmin) of Tiragolumab
Maximum Serum Concentration (Cmax) of Tiragolumab
Cmin of Atezolizumab
Cmax of Atezolizumab
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Percentage of Participants With ADAs to Atezolizumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04300647
Brief Title
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Acronym
SKYSCRAPER-04
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiragolumab plus Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
RO7092284
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
RO5541267, Tecentriq
Intervention Description
Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Time Frame
From randomization up to approximately 36 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Time Frame
Up to 36 months
Title
IRC-Assessed Duration of Response (DOR)
Time Frame
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)
Title
IRC-Assessed Disease Control Rate (DCR)
Time Frame
From randomization up to approximately 36 months
Title
Investigator-Assessed Best Clinical Response (BCR) Rate
Time Frame
From randomization up to approximately 36 months
Title
Investigator-Assessed DOR
Time Frame
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)
Title
IRC-Assessed Progression-Free Survival (PFS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Title
IRC-Assessed PFS Rate at 6 Months
Time Frame
6 months
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to 36 months)
Title
OS Rate at 6 Months and 12 Months
Time Frame
6 months, 12 months
Title
Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame
Predose and 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)
Title
Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame
Predose and 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)
Title
Cmin of Atezolizumab
Time Frame
Predose and 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)
Title
Cmax of Atezolizumab
Time Frame
Predose and 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)
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame
Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Title
Percentage of Participants With ADAs to Atezolizumab
Time Frame
Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Kaiser Permanente - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Oncology Associates of Oregon, P.C
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Mater Misericordiae Limited
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital de Caridade de Ijui; Oncologia
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Hamilton Health Sciences - Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Oncotech S.A.
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS S. Raffaele; Ginecologia Oncologica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
City
Seoul
ZIP/Postal Code
01812
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Christus Muguerza Clinica Vidriera
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64570
Country
Mexico
Facility Name
Centro Oncológico de Panamá
City
Panama
ZIP/Postal Code
0801
Country
Panama
Facility Name
The Panama Clinic
City
Panama
ZIP/Postal Code
0832-02723
Country
Panama
Facility Name
Clinica Ricardo Palma
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Bialostockie Centrum Onkologi
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143422
Country
Russian Federation
Facility Name
Chelyabisnk regional clinical center for oncology and nuclear medicine
City
Chelyabinsk
State/Province
Sverdlovsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Murmansk Regional Clinical Hospital named after P.A. Bayandin
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Taichung Veterans General Hospital; Obstetrics and Gynecology
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital; Obstetrics & Gynecology
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Mackay Memorial Hospital; Obstetrics & Gynaecology
City
Taipei City
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
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