연구제목

A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy

연구요약

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).

연구의뢰자

AstraZeneca

연구모집현황

RECRUITING

임상시험의 목적

TREATMENT

ClinicalTrials.gov 등록번호

NCT06943833

추가 연구 번호

최신갱신일

2025-06-11

연구종료일

2029-03-30

연구 버전 기록

실시기관명

facility: Research Site
status: NOT_YET_RECRUITING
city: Chelyabinsk
zip: 454087
country: Russian Federation
geoPoint: {lat=55.15402, lon=61.42915}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 111123
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 115478
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 115533
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 117997
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: NOT_YET_RECRUITING
city: Moscow
zip: 125284
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 125367
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Saint Petersburg
zip: 197758
country: Russian Federation
geoPoint: {lat=59.93863, lon=30.31413}

facility: Research Site
status: RECRUITING
city: Yekaterinburg
zip: 620036
country: Russian Federation
geoPoint: {lat=56.8519, lon=60.6122}

연구대상 상태/질환

Locally Advanced Cervical Cancer

대상질환

id: M5830
name: Uterine Cervical Neoplasms
asFound: Cervical Cancer
relevance: HIGH

id: M17342
name: Uterine Neoplasms
relevance: LOW

id: M8945
name: Genital Neoplasms, Female
relevance: LOW

id: M17315
name: Urogenital Neoplasms
relevance: LOW

id: M5825
name: Uterine Cervical Diseases
relevance: LOW

id: M17339
name: Uterine Diseases
relevance: LOW

id: M8943
name: Genital Diseases, Female
relevance: LOW

id: M2876
name: Genital Diseases
relevance: LOW

id: M2875
name: Urogenital Diseases
relevance: LOW

id: M27093
name: Female Urogenital Diseases
relevance: LOW

id: M14127
name: Pregnancy Complications
relevance: LOW

id: M8399
name: Female Urogenital Diseases and Pregnancy Complications
relevance: LOW

제품명(코드명)

활성대조약 여부

대조약 여부

위약 여부

대조약

-

중재/치료

type: BIOLOGICAL
name: Volrustomig
description: IV infusion
armGroupLabels: [Arm 1]
otherNames: [MEDI5752]

중재 방법

연구종류

INTERVENTIONAL

임상시험단계

PHASE2

배정

중재모형

SINGLE_GROUP

눈가림대상자

중재군명

Open Label

중재군 유형

label: Arm 1
type: EXPERIMENTAL
description: Volrustomig
interventionNames: [Biological: Volrustomig]

중재군 수

0

중재군 별 설명 및 등록 환자수

중재군 목표대상자 수

0

기관소재지

실시기관 전화번호

연구참여기관

국가

환자모집국가

최초 연구대상자 등록일

2025-03-31

상세내용

All participants will receive volrustomig as IV infusions

대상자 선정 및 제외기준

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.

참여 가능한 연령 하한

18 Years

참여 가능한 연령 상한

참여 가능한 표준 연령

ADULT

OLDER_ADULT

대상자 포함기준 성별

FEMALE

건강인 참여 여부

NO

실제 대상자수

36

기존 목표대상자 수(실제)

0

최종 연구대상자 수

0

최종 시험대상자 선정일

시험대상자 > 분석대상군

시험대상자 > 인구학적 정보

주요결과변수

measure: Progression-free Survival at 24 months (PFS24)
description: PFS24 is defined as the Kaplan-Meier estimate of PFS at 24 months per RECIST 1.1 or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
timeFrame: From date of first dose until 24 months.

보조결과변수

measure: Overall Survival at 36 months (OS36)
description: OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after study drug administration.
timeFrame: From date of first dose until 36 months.

measure: Progression-free Survival at 36 months (PFS36)
description: PFS36 is defined as the Kaplan-Meier estimate of PFS at 36 months per RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
timeFrame: From date of first dose until 36 months.

measure: Time to First Subsequent Therapy or death (TFST)
description: TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
timeFrame: From date of first dose until 36 months.

주요 평가 > 1차 평가변수 결과

최종 주평가변수 수집 완료일

2028-03-31

임상시험결과요약

연구책임자 전화번호

연구책임자 주소

연구실무담당자 성명

연구실무담당자 직위

연구실무담당자 전화번호

name: AstraZeneca Clinical Study Information Center
role: CONTACT
phone: 1-877-240-9479
email: information.center@astrazeneca.com

연구실무담당자 기관명