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

Launched by ASTRAZENECA · Oct 6, 2023

Keywords

ClinConnect Summary

The eVOLVE-Cervical trial is a research study looking at a new treatment called volrustomig for women with high-risk locally advanced cervical cancer, which means the cancer has spread to nearby lymph nodes but has not progressed after initial chemotherapy and radiation treatment. This study will help determine how effective and safe volrustomig is for these patients. It’s a phase III trial, meaning it’s one of the final steps before the treatment can be approved for general use. The study is currently recruiting women aged 15 and older who meet specific health criteria.

To participate, women must have a certain type of cervical cancer that hasn’t worsened after initial treatment and should be in good overall health. They will need to provide a tumor sample for testing and must not have had other treatments for cervical cancer. Participants can expect to receive either the study drug or a placebo (a dummy treatment with no active medication) and will be monitored closely for any side effects or changes in their condition. This trial offers a chance to access a potential new treatment option while contributing to important research that could help other women in the future.

Gender

FEMALE

Eligibility criteria

• 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.