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Study Name

GOG 3092

Study Title

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)

Start Date

September 22, 2023

Enrollment Status

Enrolling new patients

Sponsor

AstraZeneca

Study Type

Interventional (Clinical Trial)

Location

Trials365
2600 Kings Hwy
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Main Inclusion
  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.
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Exclusion Criteria
  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 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.
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Treatment Information

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 IIIC to IVA cervical cancer with lymph node involvement) who have not progressed following platinum-based CCRT. Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.

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Costs & Stipend Details

Unfortunately, there is no stipend available.

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General Information

Experimental: Volrustomig

Biological: Volrustomig IV Infusion

Placebo Comparator: Placebo

Other: Placebo IV Infusion

Other Name: Saline

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