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

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06079671

This phase III clinical trial is testing the effectiveness and safety of a new drug, Volrustomig, in women with high-risk locally advanced cervical cancer that has not worsened after initial treatment with chemotherapy and radiation.

Patient Parameters

Program Overview

This study is investigating whether the drug Volrustomig can help women with high-risk locally advanced cervical cancer (stages IIIC to IVA with lymph node involvement) who have not seen their cancer progress after receiving standard chemotherapy and radiation treatment. The trial is conducted globally and involves multiple centers, with participants randomly receiving either Volrustomig or a placebo.

Description

In this study, women with locally advanced cervical cancer will be randomly assigned to receive either the drug Volrustomig or a placebo. The goal is to see if Volrustomig is effective and safe for treating this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Female participants.
  • At least 15 years old.
  • Weigh more than 35 kg (about 77 pounds).
  • Diagnosed with specific types of cervical cancer (stages IIIC to IVA) with lymph node involvement.
  • Initial cancer staging done within 42 days before starting chemotherapy and radiation.
  • Provide a tumor sample to check for PD-L1 expression.
  • Cancer has not worsened after chemotherapy and radiation, and no other curative treatments are available.
  • Good overall health with a performance status of 0 or 1.
  • Healthy organ and bone marrow function.
  • Able to give informed consent.

Exclusion Criteria

  • Diagnosed with small cell or mucinous adenocarcinoma of the cervix.
  • Cancer has spread to other parts of the body.
  • Planning to undergo fertility-sparing treatment.
  • History of organ transplant.
  • Have active or past autoimmune or inflammatory disorders.
  • Have uncontrolled illnesses.
  • Have had another cancer unless treated and inactive for at least 2 years, or certain skin cancers or carcinoma in situ.
  • Have unresolved side effects from previous treatment, except for permanent side effects not expected to worsen.
  • Have or had certain types of fistulas.
  • History of severe allergic reactions to biological therapies or vaccines.
  • Use of immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • Have had a hysterectomy or will have one as part of initial cancer treatment.
  • Have had other treatments for cervical cancer besides chemotherapy and radiation.
  • Major surgery within 4 weeks before starting the study or still recovering from surgery.
  • Have received immune therapy before the study.
  • Have received a live vaccine within 30 days before starting the study.
  • Known allergy or sensitivity to the study drug or its ingredients.

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