A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Status: Recruiting
Location: See all (195) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: f
View:

‣ For inclusion in the study, patients should fulfill the following criteria:

• Female.

• Aged at least 15 years at the time of screening.

• Body weight \> 35 kg.

• Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.

• Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.

• Provision of FFPE tumor sample to assess the PD-L1 expression.

• Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.

• WHO/ECOG performance status of 0 or 1.

• Adequate organ and bone marrow function.

⁃ Capable of providing signed informed consent.

Locations
United States
Alabama
Research Site
WITHDRAWN
Birmingham
Arkansas
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WITHDRAWN
Little Rock
Arizona
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WITHDRAWN
Phoenix
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WITHDRAWN
Tucson
California
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WITHDRAWN
La Jolla
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WITHDRAWN
West Hollywood
Georgia
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WITHDRAWN
Atlanta
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WITHDRAWN
Augusta
Research Site
TERMINATED
Savannah
Illinois
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WITHDRAWN
Melrose Park
Indiana
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WITHDRAWN
Indianapolis
Louisiana
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WITHDRAWN
New Orleans
Research Site
WITHDRAWN
New Orleans
Research Site
COMPLETED
Shreveport
New York
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WITHDRAWN
New York
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WITHDRAWN
Syracuse
Ohio
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WITHDRAWN
Cleveland
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WITHDRAWN
Columbus
Oregon
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WITHDRAWN
Eugene
Pennsylvania
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WITHDRAWN
Philadelphia
Rhode Island
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WITHDRAWN
Providence
Texas
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WITHDRAWN
Dallas
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TERMINATED
Fort Worth
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WITHDRAWN
Houston
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WITHDRAWN
Tyler
Virginia
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COMPLETED
Charlottesville
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WITHDRAWN
Fairfax
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WITHDRAWN
Richmond
Other Locations
Brazil
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RECRUITING
Barretos
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RECRUITING
Belo Horizonte
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Curitiba
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NOT_YET_RECRUITING
Fortaleza
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RECRUITING
Fortaleza
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Natal
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Porto Alegre
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Porto Alegre
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Porto Velho
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Recife
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Rio De Janeiro
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Salvador
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São Paulo
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São Paulo
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Teresina
Canada
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Hamilton
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WITHDRAWN
London
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RECRUITING
Montreal
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Montreal
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WITHDRAWN
Ste-foy
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Toronto
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Toronto
China
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Beijing
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Beijing
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Changde
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Changsha
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Changsha
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Chengdu
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Chongqing
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Fuzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Harbin
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Kunming
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RECRUITING
Lanzhou
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Lanzhou
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RECRUITING
Linyi
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WITHDRAWN
Luzhou
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RECRUITING
Nanchang
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RECRUITING
Nanchang
Research Site
WITHDRAWN
Shandong
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RECRUITING
Shanghai
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Shanghai
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Shenyang
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Shenzhen
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Tianjin
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Wuhan
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Wuhan
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Xi'an
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Yibin
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Yinchuan
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Zhengzhou
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Zhengzhou
Denmark
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Aarhus N
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København Ø
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Odense
Germany
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Berlin
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Bonn
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Hamburg
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Leipzig
India
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Calicut
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Jaipur
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WITHDRAWN
Lucknow
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Madurai
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Mohali
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Nagpur
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Nashik
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Nashik
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New Delhi
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Vadodara
Italy
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WITHDRAWN
Bari
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RECRUITING
Bologna
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Catania
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Florence
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Lecco
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Milan
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Milan
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Milan
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Monza
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Napoli
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Roma
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Rome
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Turin
Japan
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Fukuoka
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Ginowan-shi
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Hidaka-shi
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Kagoshima
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Kōtoku
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Kurume-shi
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Maebashi
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Matsuyama
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Morioka
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Nagoya
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Osaka
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Sapporo
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Sapporo
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Shinjuku-ku
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Suita-shi
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Sunto-gun
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Toon-shi
Mexico
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Coyoacán
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Culiacán
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Guadalajara
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Guadalajra
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México
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México
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Mexico City
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Monterrey
Norway
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Oslo
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Trondheim
Peru
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Concepción
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Lima
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Lima
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RECRUITING
Lima
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RECRUITING
Lima
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NOT_YET_RECRUITING
Lima
Poland
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RECRUITING
Bialystok
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Gdansk
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RECRUITING
Gliwice
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WITHDRAWN
Krakow
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WITHDRAWN
Lodz
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RECRUITING
Poznan
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WITHDRAWN
Warsaw
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Wroclaw
Puerto Rico
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WITHDRAWN
San Juan
Republic of Korea
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RECRUITING
Daegu
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Goyang-si
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Gyeonggi-do
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Seoul
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Seoul
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Seoul
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Seoul
Spain
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A Coruña
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Barcelona
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Barcelona
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Córdoba
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Girona
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Hospitalet Dellobregat
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RECRUITING
Madrid
Research Site
WITHDRAWN
Madrid
Research Site
RECRUITING
Madrid
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RECRUITING
Madrid
Research Site
WITHDRAWN
Palma De Mallorca
Research Site
WITHDRAWN
Valencia
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RECRUITING
Valencia
Taiwan
Research Site
RECRUITING
Changhua
Research Site
RECRUITING
Kaohsiung City
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RECRUITING
Kaohsiung City
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New Taipei City
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Taichung
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RECRUITING
Taichung
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Tainan
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Taipei
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Taipei
Research Site
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Taoyuan District
Thailand
Research Site
RECRUITING
Bangkok
Research Site
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Bangkok
Research Site
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Bangkok
Research Site
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Muang
Research Site
RECRUITING
Udon Thani
Turkey
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RECRUITING
Adana
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Ankara
Research Site
WITHDRAWN
Istanbul
Research Site
WITHDRAWN
Istanbul
Research Site
RECRUITING
Karşıyaka
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-09-22
Estimated Completion Date: 2029-10-18
Participants
Target number of participants: 800
Treatments
Experimental: Volrustomig
Volrustomig
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Gynecologic Oncology Group Foundation, European Network for Gynaecological Oncological Trial Groups

This content was sourced from clinicaltrials.gov

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