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A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)

NCT06943833

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Locally Advanced Cervical Cancer

Interventions: Volrustomig

Countries: Russia

This is a phase II single-arm open-label study to investigate the efficacy and safety of volrustomig in women with FIGO 2018 stage IIIA to IVA cervical cancer who have not progressed following platinum-based concurrent chemoradiation therapy (CCRT).

Eligibility overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

* Female.
* Aged at least 18 years at the time of screening.
* Body weight \> 35 kg.
* Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
* Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
* Known PD-L1 status.
* Must not have progressed following CCRT.
* World Health Organization/The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1.
* Adequate organ and bone marrow function.
* Capable of providing signed informed consent.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

* 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 or allogenic stem cell 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.
* 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).
* Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
* Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
* Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
* Exposure to immune mediated therapy prior to the study for any indication.
* Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
* Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.
Locations (12)
  • Arkhangelsk, Russia
  • Krasnoyarsk, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Ufa, Russia
  • Yekaterinburg, Russia