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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06079671
Phase
PHASE3
Status
Recruiting
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Conditions

  • Locally Advanced Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Volrustomig — BIOLOGICAL
    IV Infusion
  • Placebo — OTHER
    IV Infusion

Study Details

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 IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Key Dates

Start date
Sep 22, 2023
Status verified
May 2026
Primary completion
Nov 26, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Volrustomig
    Volrustomig
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) [ Time Frame: Up to approximately 7 years ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SitePhoenixArizona85016-
Research SiteTucsonArizona85711-
Research SiteLittle RockArkansas72205-
Research SiteLa JollaCalifornia92093-
Research SiteWest HollywoodCalifornia90048-
Research SiteAtlantaGeorgia30322-
Research SiteAugustaGeorgia30912-
Research SiteSavannahGeorgia31405-
Research SiteMelrose ParkIllinois60160-
Research SiteIndianapolisIndiana46202-
Research SiteNew OrleansLouisiana70112-
Research SiteNew OrleansLouisiana70121-
Research SiteShreveportLouisiana71103-
Research SiteNew YorkNew York10016-
Research SiteSyracuseNew York13210-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43210-
Research SiteEugeneOregon97401-
Research SitePhiladelphiaPennsylvania19107-
Research SiteProvidenceRhode Island02905-
Research SiteDallasTexas75390-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteTylerTexas75702-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteRichmondVirginia23298-

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