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
Sex
FEMALE
Min age
15 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) — Up to approximately 7 years 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.
Trial sites (205)
Facility
City
Region
Status
Research Site
Birmingham
Alabama
Withdrawn
Research Site
Phoenix
Arizona
Withdrawn
Research Site
Tucson
Arizona
Withdrawn
Research Site
Little Rock
Arkansas
Withdrawn
Research Site
La Jolla
California
Withdrawn
Research Site
West Hollywood
California
Withdrawn
Research Site
Atlanta
Georgia
Withdrawn
Research Site
Augusta
Georgia
Withdrawn
Research Site
Savannah
Georgia
Terminated
Research Site
Melrose Park
Illinois
Withdrawn
Research Site
Indianapolis
Indiana
Withdrawn
Research Site
New Orleans
Louisiana
Withdrawn
Research Site
New Orleans
Louisiana
Withdrawn
Research Site
Shreveport
Louisiana
Completed
Research Site
New York
New York
Withdrawn
Research Site
Syracuse
New York
Withdrawn
Research Site
Cleveland
Ohio
Withdrawn
Research Site
Columbus
Ohio
Withdrawn
Research Site
Eugene
Oregon
Withdrawn
Research Site
Philadelphia
Pennsylvania
Withdrawn
Research Site
Providence
Rhode Island
Withdrawn
Research Site
Dallas
Texas
Withdrawn
Research Site
Fort Worth
Texas
Terminated
Research Site
Houston
Texas
Withdrawn
Research Site
Tyler
Texas
Withdrawn
Research Site
Charlottesville
Virginia
Completed
Research Site
Fairfax
Virginia
Withdrawn
Research Site
Richmond
Virginia
Withdrawn
Research Site
Barretos
Brazil
Recruiting
Research Site
Belo Horizonte
Brazil
Recruiting
Research Site
Curitiba
Brazil
Recruiting
Research Site
Fortaleza
Brazil
Recruiting
Research Site
Fortaleza
Brazil
Recruiting
Research Site
Goiânia
Brazil
Not Yet Recruiting
Research Site
Ijuí
Brazil
Not Yet Recruiting
Research Site
Natal
Brazil
Recruiting
Research Site
Porto Alegre
Brazil
Not Yet Recruiting
Research Site
Porto Alegre
Brazil
Recruiting
Research Site
Porto Alegre
Brazil
Recruiting
Research Site
Porto Velho
Brazil
Recruiting
+ 165 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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