Recruiting
Phase 3
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
Condition(s) studied
Locally Advanced Cervical Cancer
Investigational drug(s) / intervention(s)
Volrustomig: IV Infusion
Placebo: IV Infusion
Study 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
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 |
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.
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