RECRUITING

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

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Conditions

Locally Advanced Cervical CancerLocally Advanced Cervical Cancer;Adolescent and Young Adult;Volrustomig

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-09-22
Study Completion:2029-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06079671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female.
  2. 2. Aged at least 15 years at the time of screening.
  3. 3. Body weight \> 35 kg.
  4. 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. 5. Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
  6. 6. Provision of FFPE tumor sample to assess the PD-L1 expression.
  7. 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. 8. WHO/ECOG performance status of 0 or 1.
  9. 9. Adequate organ and bone marrow function.
  10. 10. Capable of providing signed informed consent.
  1. 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
  2. 2. Evidence of metastatic disease.
  3. 3. Intent to administer a fertility-sparing treatment regimen.
  4. 4. History of organ transplant or allogenic stem cell transplant.
  5. 5. Active or prior documented autoimmune or inflammatory disorders.
  6. 6. Uncontrolled intercurrent illness.
  7. 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. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
  9. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
  10. 10. History of anaphylaxis to any biologic therapy or vaccine.
  11. 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).
  12. 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. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
  14. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
  15. 15. Exposure to immune mediated therapy prior to the study for any indication.
  16. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
  17. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Phoenix, Arizona, 85016
United States
Research Site
Tucson, Arizona, 85711
United States
Research Site
Little Rock, Arkansas, 72205
United States
Research Site
La Jolla, California, 92093
United States
Research Site
West Hollywood, California, 90048
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Augusta, Georgia, 30912
United States
Research Site
Savannah, Georgia, 31405
United States
Research Site
Melrose Park, Illinois, 60160
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
New Orleans, Louisiana, 70112
United States
Research Site
New Orleans, Louisiana, 70121
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
New York, New York, 10016
United States
Research Site
Syracuse, New York, 13210
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Eugene, Oregon, 97401
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Providence, Rhode Island, 02905
United States
Research Site
Dallas, Texas, 75390
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Tyler, Texas, 75702
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2029-10-18

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2029-10-18

Terms related to this study

Keywords Provided by Researchers

  • Locally Advanced Cervical Cancer;
  • Adolescent and Young Adult;
  • Volrustomig

Additional Relevant MeSH Terms

  • Locally Advanced Cervical Cancer