Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06079671
Other study ID # D7984C00002
Secondary ID GOG-3092ENGOT-cx
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 22, 2023
Est. completion date October 24, 2029

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date October 24, 2029
Est. primary completion date February 19, 2027
Accepts healthy volunteers No
Gender Female
Age group 15 Years and older
Eligibility Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. Aged at least 15 years at the time of screening. 3. Body weight > 35 kg. 4. Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement. 5. Initial staging procedures performed no more than 42 days prior to the first dose of CCRT. 6. Provision of tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant. 5. Active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. 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. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. 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). 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Study Design


Intervention

Biological:
Volrustomig
IV Infusion
Other:
Placebo
IV Infusion

Locations

Country Name City State
Brazil Research Site Barretos
Brazil Research Site Belo Horizonte
Brazil Research Site Curitiba
Brazil Research Site Fortaleza
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Porto Velho
Brazil Research Site Rio de Janeiro
Brazil Research Site Salvador
Brazil Research Site Sao Paulo
Brazil Research Site São Paulo
Brazil Research Site Teresina
Canada Research Site Hamilton Ontario
Canada Research Site London Ontario
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Ste-Foy Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
China Research Site Beijing
China Research Site Changde
China Research Site Changsha
China Research Site Changsha
China Research Site Chengdu
China Research Site Chongqing
China Research Site Fuzhou
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Hangzhou
China Research Site Harbin
China Research Site Kunming
China Research Site Lanzhou
China Research Site Lanzhou
China Research Site Luzhou
China Research Site Nanchang
China Research Site Nanchang
China Research Site Shandong
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenyang
China Research Site TianJin
China Research Site Wuhan
China Research Site Wuhan
China Research Site Xi'an
China Research Site Yinchuan
China Research Site Zhengzhou
China Research Site Zhengzhou
Denmark Research Site Aarhus N
Denmark Research Site København Ø
Denmark Research Site Odense C
India Research Site Calicut
India Research Site Jaipur
India Research Site Lucknow
India Research Site Madurai
India Research Site Mohali
India Research Site Nagpur
India Research Site Nashik
India Research Site Nashik
India Research Site New Delhi
India Research Site Vadodara
Italy Research Site Napoli
Italy Research Site Rome
Italy Research Site Turin
Japan Research Site Fukuoka-shi
Japan Research Site Hidaka-shi
Japan Research Site Kagoshima-shi
Japan Research Site Koto-ku
Japan Research Site Kurume-shi
Japan Research Site Maebashi-shi
Japan Research Site Matsuyama-shi
Japan Research Site Morioka-shi
Japan Research Site Nagoya-shi
Japan Research Site Nakagami-gun
Japan Research Site Osaka-shi
Japan Research Site Sapporo-shi
Japan Research Site Sapporo-shi
Japan Research Site Shinjuku-ku
Japan Research Site Suita-shi
Japan Research Site Sunto-gun
Japan Research Site Toon-Shi
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Mexico Research Site Ciudad de México
Mexico Research Site Coyoacan
Mexico Research Site Culiacan
Mexico Research Site Guadalajara
Mexico Research Site Guadalajra
Mexico Research Site Mexico
Mexico Research Site México
Mexico Research Site Monterrey
Norway Research Site Oslo
Norway Research Site Trondheim
Peru Research Site Concepción
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Poland Research Site Bialystok
Poland Research Site Gdansk
Poland Research Site Gliwice
Poland Research Site Kraków
Poland Research Site Lódz
Poland Research Site Poznan
Poland Research Site Warszawa
Poland Research Site Wroclaw
Puerto Rico Research Site San Juan
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Cordoba
Spain Research Site Girona
Spain Research Site Hospitalet deLlobregat
Spain Research Site La Coruna
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Palma de Mallorca
Spain Research Site Valencia
Spain Research Site Valencia
Taiwan Research Site Kaohsiung
Taiwan Research Site Kaohsiung city
Taiwan Research Site New Taipei
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Taipei
Taiwan Research Site Taoyuan
Turkey Research Site Ankara
Turkey Research Site Ankara
Turkey Research Site Istanbul
Turkey Research Site Istanbul
United States Research Site Atlanta Georgia
United States Research Site Augusta Georgia
United States Research Site Birmingham Alabama
United States Research Site Charlottesville Virginia
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Eugene Oregon
United States Research Site Fort Worth Texas
United States Research Site Houston Texas
United States Research Site Indianapolis Indiana
United States Research Site La Jolla California
United States Research Site Little Rock Arkansas
United States Research Site Melrose Park Illinois
United States Research Site New Orleans Louisiana
United States Research Site New Orleans Louisiana
United States Research Site New York New York
United States Research Site Philadelphia Pennsylvania
United States Research Site Phoenix Arizona
United States Research Site Providence Rhode Island
United States Research Site Richmond Virginia
United States Research Site Savannah Georgia
United States Research Site Shreveport Louisiana
United States Research Site Syracuse New York
United States Research Site Tucson Arizona
United States Research Site Tyler Texas
United States Research Site West Hollywood California

Sponsors (3)

Lead Sponsor Collaborator
AstraZeneca European Network for Gynaecological Oncological Trial Groups, Gynecologic Oncology Group Foundation

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  China,  Denmark,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Norway,  Peru,  Poland,  Puerto Rico,  Spain,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) in participants with PD-L1 expression based on the investigator assessment PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier. The study duration will be approximately 40 months.
Secondary Progression-free Survival (PFS) in participants regardless of PD-L1 expression based on the investigator assessment PFS is defined as the time from date of randomization until RECIST 1.1-defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier. The study duration will be approximately 40 months
Secondary Overall Survival (OS) in participants regardless of PD-L1 expression. OS defined as time from randomization until the date of death due to any cause. The study duration will be approximately 6 years.
Secondary Overall Survival (OS) in participants with PD-L1 expression OS defined as time from randomization until the date of death due to any cause. The study duration will be approximately 6 years.
Secondary Objective Response Rate (ORR) in participants with PD-L1 expression/regardless of PD-L1 expression. ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1 The study duration will be approximately 40 months
Secondary Duration of Response (DoR) in participants with a CR or PR in the PD-L1 expression analysis set/FAS. DoR in participants with a CR or PR: Time from date of first detection of CR or PR until the date of RECIST 1.1-defined radiological progression or histopathologically confirmed progression. The study duration will be approximately 40 months
Secondary Time to First Subsequent Therapy or death (TFST) in the PD-L1 expression analysis set/FAS 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. The study duration will be approximately 40 months
Secondary Time to second progression or death (PFS2) in the PD-L1 expression analysis set/FAS. PFS2: The time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice. The study duration will be approximately 6 years.
Secondary PFS by BICR in the PD-L1 expression analysis set/FAS. Endpoints based on the PFS by BICR assessment according to RECIST 1.1. The study duration will be approximately 40 months
Secondary The incidence of local progression, and distant disease progression as the first documented progression event in the PD-L1 expression analysis set/FAS. Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence. The study duration will be approximately 40 months
Secondary PK of Volrustomig Concentration of Volrustomig in serum. The study duration will be approximately 40 months.
Secondary The immunogenicity of volrustomig. Incidence of ADAs against volrustomig in serum. The study duration will be approximately 40 months
Secondary Incidence of adverse events of Volrustomig compared to placebo; An AE is definded as the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a patient or clinical study participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. The study duration will be approximately 40 months.
Secondary Participant-reported disease-related symptoms Change from baseline as measured by the European Organization for Research and Treatment of Cancer IL318 (EORTC IL318, Symptom Experience subscale of the EORTC Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24)). The score of scale for EORTC IL318 is from 1-4. The study duration will be approximately 40 months.
Secondary Participant-reported physical functioning Change from baseline of physical functioning as measured by the Patient Reported Outcomes Measurement Information System - Short Form - Physical Functioning 8c (PROMIS SF-PF 8c). The score of scale for PROMIS SF-PF 8c is from 1-5. The study duration will be approximately 40 months.
Secondary Participant-reported global health status/Quality of Life. Change from baseline of Global Health Status/ Quality of Life (GHS/QoL) as measured by the European Organization for Research and Treatment of Cancer IL172 (EORTC IL172). The score of scale for EORTC IL172 is from 1-7. The study duration will be approximately 40 months.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03225443 - Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy N/A
Completed NCT05059119 - Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
Recruiting NCT06055738 - Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC Phase 2
Recruiting NCT06156514 - Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer Phase 3
Completed NCT03298893 - Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months Phase 1/Phase 2
Withdrawn NCT01514955 - An Initial Feasibility Study to Integrate MRI Based Brachytherapy and CT/MR Fused INRT in Treatment of Advance Cervical Cancer Phase 1
Recruiting NCT05950087 - Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
Recruiting NCT04884906 - Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer Phase 2
Not yet recruiting NCT05799469 - Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer Phase 2
Recruiting NCT05311566 - PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer Phase 2
Terminated NCT02045433 - Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer Phase 2
Recruiting NCT06237257 - A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer Phase 2
Not yet recruiting NCT06288373 - Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC Phase 2/Phase 3
Not yet recruiting NCT06288360 - Neoadjuvant Immunochemotherapy in PD-L1-negative LACC Phase 2
Recruiting NCT06068387 - A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis N/A
Recruiting NCT05378087 - Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer N/A
Recruiting NCT03963882 - NAC Followed by RH for the Treatment of LACC Phase 2
Recruiting NCT01938105 - Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer Phase 2
Active, not recruiting NCT01793701 - Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer Phase 1/Phase 2
Completed NCT01230996 - Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer Phase 1/Phase 2