Fact CheckerSign in

NCT06079671RecruitingPhase 3

A trial to learn if volrustomig is safe and efficacious in women and young adults with locally advanced cervical cancer.

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2026

Brief summary (registry, in English)

To demonstrate the superiority of volrustomig relative to placebo by assessment of PFS, in all randomized participants.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
101 (estimated)
First submitted
31 Oct 2023
Start date
12 Apr 2024
Lead sponsor
AstraZeneca AB
NCT number
NCT06079671
EU CT number
2023-504374-38-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 101
  • 41 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
  • 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.
  • History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
  • 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.

Other illness

  • Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.
  • Evidence of metastatic disease.
  • History of organ transplant or allogenic stem cell transplant.
  • Uncontrolled intercurrent illness.

Other

  • Intent to administer a fertility-sparing treatment regimen.

Who the study is looking for

  • Female.
  • Capable of providing signed informed consent.
  • Aged at least 15 years at the time of screening. Note: Participants < 18 years of age: physical changes should be aligned with Tanner Stage III.
  • Body weight > 35 kg.
  • Histologically confirmed cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, FIGO 2018 Stage IIIA to IVA cervical cancer, no evidence of metastatic disease.
  • Initial staging procedures performed prior to initiation of any component of definitive treatment (CCRT).
  • Provision of FFPE 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; duration of life expectancy of ≥ 12 weeks.
  • Adequate organ and bone marrow function.

Sex: Female · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
Coordinator of this site? Confirm its status
BonnGermanyRecruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
Coordinator of this site? Confirm its status
EssenGermanyRecruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
Universitaet Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting
Region Midtjylland
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Rigshospitalet
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkRecruiting
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainRecruiting
Institut Català d'Oncologia
Coordinator of this site? Confirm its status
GironaSpainRecruiting
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Fundación Instituto Valenciano de Oncología
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Careggi University Hospital
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Alessandro Manzoni Hospital
Coordinator of this site? Confirm its status
LeccoItalyRecruiting
European Institute Of Oncology S.r.l.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Oslo University Hospital HF
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
Universitetssykehuset Nord-Norge HF
Coordinator of this site? Confirm its status
TromsoeNorwayRecruiting
St. Olavs hospital HF
Coordinator of this site? Confirm its status
TrondheimNorwayRecruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
Coordinator of this site? Confirm its status
BialystokPolandRecruiting
Jagiellonskie Centrum Innowacji Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
Coordinator of this site? Confirm its status
GdanskPolandRecruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
GliwicePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Coordinator of this site? Confirm its status
LodzPolandRecruiting
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Coordinator of this site? Confirm its status
PoznanPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
Coordinator of this site? Confirm its status
WroclawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.