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)

The University of Virginia seeks adult women ages 18 years and older with locally advanced cervical cancer.

You may be eligible for this study if you have histologically documented FIGO 2018 stage IIIC-IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamos carcinoma, with lymph node involvement.

This study aims to determine if Volrustomig, a study drug and monovalent, bispecific, humanized IgG1 mAb, is an effective anti-cancer therapy for patients with solid tumors who have not progressed following platinum-based, concurrent chemoradiation therapy. This study is a double-blinded trial in which neither you nor the researcher knows which treatment or intervention you are receiving until the clinical trial is over.

Participants will be randomized (assigned by chance) in a 1:1 ratio to 2 groups, Arm A or Arm B.
• Arm A: the study drug Volrustomig only
• Arm B: a placebo only

Both Volrustomig and placebo will be administered as an IV infusion. The length of your participation in this study depends on how your cancer responds to the study drug. It also depends on whether you have side effects from the study drug that makes you want to stop receiving it.

This study involves blood sampling, tumor biopsies, physical examination, imaging, and an electrocardiogram (ECG).
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Study Details | Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) | ClinicalTrials.gov