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)

JRCT ID: jRCT2031230436

Registered date:07/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally Advanced Cervical Cancer
• Date of first enrollment: 13/10/2023
• Target sample size: 80
• Countries of recruitment: India,Japan,South Korea,Japan,Taiwan,Japan,China,Japan,Mexico,Japan,Peru,Japan,US,Japan,Brazil,Japan,Canada,Japan,Spain,Japan,Italy,Japan,UK,Japan,Germany,Japan,Poland,Japan,Turkey,Japan,Denmark,Japan,Norway,Japan
• Study type: Interventional
• Intervention(s): Administer Volrustomig or placebo (0.9% sodium chloride injection)

Outcome(s)

• Primary Outcome: To demonstrate the superiority of volrustomig relative to placebo by assessment of PFS, in participants with PD L1 high expression.

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Female

Include 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 IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement.

5. Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.

6. Provision of 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.

Exclude 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.

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 or more 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06079671