Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
eVOLVECervical
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)
5 other identifiers
interventional
800
19 countries
204
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2023
Longer than P75 for phase_3
204 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
April 30, 2026
April 1, 2026
4.2 years
September 4, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Up to approximately 7 years
Secondary Outcomes (13)
Overall Survival (OS) in all randomized participants
Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
Up to approximately 7 years
- +8 more secondary outcomes
Study Arms (2)
Volrustomig
EXPERIMENTALVolrustomig
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Female.
- Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III.
- 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 56 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; duration of life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
You may not qualify if:
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant or allogenic stem cell transplant.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
- Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
- Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
- History of anaphylaxis to any biologic therapy or vaccine.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
- Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
- Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
- Exposure to immune mediated therapy prior to the study for any indication.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Gynecologic Oncology Group Foundationcollaborator
- European Network for Gynaecological Oncological Trial Groupscollaborator
Study Sites (204)
Research Site
Birmingham, Alabama, 35233, United States
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Phoenix, Arizona, 85016, United States
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Tucson, Arizona, 85711, United States
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Little Rock, Arkansas, 72205, United States
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La Jolla, California, 92093, United States
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West Hollywood, California, 90048, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30912, United States
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Savannah, Georgia, 31405, United States
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Melrose Park, Illinois, 60160, United States
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Indianapolis, Indiana, 46202, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71103, United States
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New York, New York, 10016, United States
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Syracuse, New York, 13210, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Eugene, Oregon, 97401, United States
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Philadelphia, Pennsylvania, 19107, United States
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Providence, Rhode Island, 02905, United States
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Dallas, Texas, 75390, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23298, United States
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30130-100, Brazil
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Curitiba, 80730-150, Brazil
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Fortaleza, 60336-045, Brazil
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Fortaleza, 60430-230, Brazil
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Goiânia, 74110-060, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90570-060, Brazil
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Porto Alegre, 90619-900, Brazil
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Porto Alegre, 98850-170, Brazil
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Porto Velho, 76834-899, Brazil
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Recife, 52010-075, Brazil
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Rio de Janeiro, 20220-410, Brazil
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Salvador, 40050 410, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01323-000, Brazil
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São Paulo, 1323001, Brazil
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Teresina, 64049-200, Brazil
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Hamilton, Ontario, L8V 1C3, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Ste-Foy, Quebec, G1V 4G2, Canada
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Beijing, 100026, China
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Beijing, 100142, China
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Beijing, 100730, China
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Changde, 415000, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610044, China
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Chongqing, 400030, China
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Fuzhou, 350014, China
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Ganzhou, 341000, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Kunming, 650118, China
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Lanzhou, 730000, China
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Lanzhou, 730050, China
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Linyi, 276001, China
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Luzhou, 646000, China
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Nanchang, 330006, China
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Nanchang, 330029, China
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Shandong, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Shenyang, 110004, China
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Shenzhen, 518036, China
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Shenzhen, 518116, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yibin, 610500, China
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Yinchuan, 750004, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Zhuzhou, 412007, China
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Aarhus N, 8200, Denmark
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København Ø, 2100, Denmark
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Odense, 5000, Denmark
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Calicut, 673601, India
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Jaipur, 302017, India
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Lucknow, 226003, India
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Madurai, 625107, India
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Mohali, 160055, India
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Nagpur, 440001, India
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Nashik, 422009, India
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Nashik, 422011, India
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New Delhi, 11029, India
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Vadodara, 391760, India
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Catania, 95126, Italy
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Florence, 50141, Italy
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Lecco, 23900, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Roma, 161, Italy
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Rome, 00168, Italy
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Turin, 10128, Italy
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Fukuoka, 812-8582, Japan
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Ginowan-shi, 901-2725, Japan
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Hidaka-shi, 350-1298, Japan
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Kagoshima, 890-8520, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Maebashi, 371-8511, Japan
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Matsuyama, 791-0280, Japan
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Morioka, 028-3695, Japan
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Nagoya, 464-8681, Japan
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Osaka, 541-8567, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8638, Japan
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Shinjuku-ku, 160-8582, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Coyoacán, 04380, Mexico
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Culiacán, 80040, Mexico
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Guadalajara, 44650, Mexico
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Guadalajra, 44260, Mexico
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Mexico City, 03240, Mexico
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México, 04700, Mexico
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México, 14080, Mexico
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Monterrey, 64460, Mexico
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Oslo, 424, Norway
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Trondheim, 7030, Norway
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Concepción, 12125, Peru
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Lima, 15036, Peru
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Lima, 15038, Peru
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Lima, 15102, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Lima, Lima39, Peru
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Bialystok, 15-027, Poland
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Gdansk, 80-214, Poland
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Gliwice, 44-101, Poland
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Krakow, 30-348, Poland
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Lodz, 90-513, Poland
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Poznan, 61-866, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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San Juan, 00927, Puerto Rico
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Daegu, 42601, South Korea
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Goyang-si, 10408, South Korea
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Gyeonggi-do, 13605, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 5505, South Korea
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A Coruña, 15009, Spain
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Girona, 17007, Spain
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Hospitalet deLlobregat, 08907, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Palma de Mallorca, 07010, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 81362, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Muang, 50200, Thailand
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Udon Thani, 41330, Thailand
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Adana, 01250, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06490, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2023
First Posted
October 12, 2023
Study Start
September 22, 2023
Primary Completion (Estimated)
November 26, 2027
Study Completion (Estimated)
September 30, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.