Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06079671

PHASE3

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2023-09-22

Completion Date

2030-09-30

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Locally Advanced Cervical Cancer

Interventions

BIOLOGICAL

Volrustomig

IV Infusion

OTHER

Placebo

IV Infusion

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. 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. 3. Body weight \> 35 kg. 4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. 5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT. 6. Provision of FFPE tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant or allogenic stem cell transplant. 5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. 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. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. 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. 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Locations (205)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

La Jolla, California, United States

Research Site

West Hollywood, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Augusta, Georgia, United States

Research Site

Savannah, Georgia, United States

Research Site

Melrose Park, Illinois, United States

Research Site

Indianapolis, Indiana, United States

Research Site

New Orleans, Louisiana, United States

Research Site

New Orleans, Louisiana, United States

Research Site

Shreveport, Louisiana, United States

Research Site

New York, New York, United States

Research Site

Syracuse, New York, United States

Research Site

Cleveland, Ohio, United States

Research Site

Columbus, Ohio, United States

Research Site

Eugene, Oregon, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Providence, Rhode Island, United States

Research Site

Dallas, Texas, United States

Research Site

Fort Worth, Texas, United States

Research Site

Houston, Texas, United States

Research Site

Tyler, Texas, United States

Research Site

Charlottesville, Virginia, United States

Research Site

Fairfax, Virginia, United States

Research Site

Richmond, Virginia, United States

Research Site

Barretos, Brazil

Research Site

Belo Horizonte, Brazil

Research Site

Curitiba, Brazil

Research Site

Fortaleza, Brazil

Research Site

Fortaleza, Brazil

Research Site

Goiânia, Brazil

Research Site

Ijuí, Brazil

Research Site

Natal, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Velho, Brazil

Research Site

Recife, Brazil

Research Site

Rio de Janeiro, Brazil

Research Site

Salvador, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Teresina, Brazil

Research Site

Hamilton, Ontario, Canada

Research Site

London, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Ste-Foy, Quebec, Canada

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Changde, China

Research Site

Changsha, China

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Chengdu, China

Research Site

Chongqing, China

Research Site

Fuzhou, China

Research Site

Ganzhou, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Hangzhou, China

Research Site

Harbin, China

Research Site

Kunming, China

Research Site

Lanzhou, China

Research Site

Lanzhou, China

Research Site

Linyi, China

Research Site

Luzhou, China

Research Site

Nanchang, China

Research Site

Nanchang, China

Research Site

Shandong, China

Research Site

Shanghai, China

Research Site

Shanghai, China

Research Site

Shenyang, China

Research Site

Shenzhen, China

Research Site

Shenzhen, China

Research Site

Tianjin, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Xi'an, China

Research Site

Yibin, China

Research Site

Yinchuan, China

Research Site

Zhengzhou, China

Research Site

Zhengzhou, China

Research Site

Zhuzhou, China

Research Site

Aarhus N, Denmark

Research Site

København Ø, Denmark

Research Site

Odense, Denmark

Research Site

Berlin, Germany

Research Site

Bonn, Germany

Research Site

Hamburg, Germany

Research Site

Leipzig, Germany

Research Site

Calicut, India

Research Site

Jaipur, India

And 105 more locations on ClinicalTrials.gov

Clinical Research Directory

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (205)