Study Name
Study Title
Start Date
Enrollment Status
Sponsor
Study Type
Location
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Main Inclusion
- Female.
- Aged at least 15 years at the time of screening.
- Body weight > 35 kg.
- Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement.
- Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
- Provision of tumor sample to assess the PD-L1 expression.
- Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
- WHO/ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
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Exclusion Criteria
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- 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.
- Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
- Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
- 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
Other: Placebo IV Infusion
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