Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
Cervical Cancer
Unknown Primary
15 Years and older, Female
D7984C00002 (primary)
NCI-2024-05317
165663
2023-504374-38-00
ENGOT-cx19/GEICO
GOG-3092
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.
Objectives
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive
treatment with Volrustomig or Placebo.
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.
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 42 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.
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. 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).
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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.