Clinical Trials List
Protocol NumberD7984C00002
NCT Number(ClinicalTrials.gov Identfier)NCT06079671
Active
2023-07-01 - 2030-02-28
Phase III
Not yet recruiting1
Recruiting10
ICD-10C53.9
Malignant neoplasm of cervix uteri, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9180.9
Malignant neoplasm of cervix uteri, unspecified
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)
-
Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 陳威君 Division of Obstetrics & Gynecology
- 黃彥綾 Division of Radiology
- 周宏學 Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- 張淑涵 Department of Traditional Chinese Medicine
- 黃寬仁 Division of Obstetrics & Gynecology
- Min-Yu Chen 無
- 張宸邠 Division of Obstetrics & Gynecology
- Ting-Chang Chang Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
- HSIU-JUNG TUNG Division of Obstetrics & Gynecology
- 林士敏 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Jen Chen Division of Obstetrics & Gynecology
- 胡育文 Division of Radiation Therapy
- Yen-Hou Chang Division of Obstetrics & Gynecology
- 沈書慧 Division of Radiology
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- 楊思婷 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 蔡曉文 Division of Obstetrics & Gynecology
- 黃哲勳 Division of Radiology
- 蔡祥維 Division of Obstetrics & Gynecology
- 林裕為 Division of Radiation Therapy
- 蔣安仁 Division of Obstetrics & Gynecology
- 簡茹君 Division of Radiation Therapy
- 黃俞憲 Division of Radiation Therapy
- 陳三農 Division of Obstetrics & Gynecology
- 王威登 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 宋鈺雯 Division of Obstetrics & Gynecology
- Yin-Yi Chang Division of Obstetrics & Gynecology
- 張正昌 Division of Obstetrics & Gynecology
- Wei-Chun Chang Division of Obstetrics & Gynecology
- Wu-Chou Lin Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally Advanced Cervical Cancer
Objectives
The primary objective of this trial is to evaluate the efficacy and safety of volrustomig compared with placebo in subjects with high-risk locally advanced cervical cancer that has not progressed after concurrent chemoradiation therapy.
Test Drug
Volrustomig
Active Ingredient
MEDI5752
Dosage Form
Lyophilized product for solution for infusion
Dosage
50 mg/mL
Endpoints
Primary Outcome Measures :
Progression-free Survival (PFS) in participants with PD-L1 expression based on the investigator assessment [ Time Frame: The study duration will be approximately 40 months. ]
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.
Secondary Outcome Measures :
Progression-free Survival (PFS) in participants regardless of PD-L1 expression based on the investigator assessment [ Time Frame: The study duration will be approximately 40 months ]
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.
Overall Survival (OS) in participants regardless of PD-L1 expression. [ Time Frame: The study duration will be approximately 6 years. ]
OS defined as time from randomization until the date of death due to any cause.
Overall Survival (OS) in participants with PD-L1 expression [ Time Frame: The study duration will be approximately 6 years. ]
OS defined as time from randomization until the date of death due to any cause.
Objective Response Rate (ORR) in participants with PD-L1 expression/regardless of PD-L1 expression. [ Time Frame: The study duration will be approximately 40 months ]
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Duration of Response (DoR) in participants with a CR or PR in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
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.
Time to First Subsequent Therapy or death (TFST) in the PD-L1 expression analysis set/FAS [ Time Frame: The study duration will be approximately 40 months ]
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.
Time to second progression or death (PFS2) in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 6 years. ]
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.
PFS by BICR in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
Endpoints based on the PFS by BICR assessment according to RECIST 1.1.
The incidence of local progression, and distant disease progression as the first documented progression event in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence.
PK of Volrustomig [ Time Frame: The study duration will be approximately 40 months. ]
Concentration of Volrustomig in serum.
The immunogenicity of volrustomig. [ Time Frame: The study duration will be approximately 40 months ]
Incidence of ADAs against volrustomig in serum.
Incidence of adverse events of Volrustomig compared to placebo; [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported disease-related symptoms [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported physical functioning [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported global health status/Quality of Life. [ Time Frame: The study duration will be approximately 40 months. ]
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.
Progression-free Survival (PFS) in participants with PD-L1 expression based on the investigator assessment [ Time Frame: The study duration will be approximately 40 months. ]
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.
Secondary Outcome Measures :
Progression-free Survival (PFS) in participants regardless of PD-L1 expression based on the investigator assessment [ Time Frame: The study duration will be approximately 40 months ]
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.
Overall Survival (OS) in participants regardless of PD-L1 expression. [ Time Frame: The study duration will be approximately 6 years. ]
OS defined as time from randomization until the date of death due to any cause.
Overall Survival (OS) in participants with PD-L1 expression [ Time Frame: The study duration will be approximately 6 years. ]
OS defined as time from randomization until the date of death due to any cause.
Objective Response Rate (ORR) in participants with PD-L1 expression/regardless of PD-L1 expression. [ Time Frame: The study duration will be approximately 40 months ]
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Duration of Response (DoR) in participants with a CR or PR in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
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.
Time to First Subsequent Therapy or death (TFST) in the PD-L1 expression analysis set/FAS [ Time Frame: The study duration will be approximately 40 months ]
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.
Time to second progression or death (PFS2) in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 6 years. ]
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.
PFS by BICR in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
Endpoints based on the PFS by BICR assessment according to RECIST 1.1.
The incidence of local progression, and distant disease progression as the first documented progression event in the PD-L1 expression analysis set/FAS. [ Time Frame: The study duration will be approximately 40 months ]
Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence.
PK of Volrustomig [ Time Frame: The study duration will be approximately 40 months. ]
Concentration of Volrustomig in serum.
The immunogenicity of volrustomig. [ Time Frame: The study duration will be approximately 40 months ]
Incidence of ADAs against volrustomig in serum.
Incidence of adverse events of Volrustomig compared to placebo; [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported disease-related symptoms [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported physical functioning [ Time Frame: The study duration will be approximately 40 months. ]
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.
Participant-reported global health status/Quality of Life. [ Time Frame: The study duration will be approximately 40 months. ]
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.
Inclution Criteria
Inclusion Criteria:
For inclusion in the study, patients should fulfill the following criteria:
Female.
Aged at least 15 years at the time of screening.
Body weight > 35 kg.
Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement.
Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
Provision of 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.
Adequate organ and bone marrow function.
Capable of providing signed informed consent.
For inclusion in the study, patients should fulfill the following criteria:
Female.
Aged at least 15 years at the time of screening.
Body weight > 35 kg.
Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement.
Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
Provision of 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.
Adequate organ and bone marrow function.
Capable of providing signed informed consent.
Exclusion Criteria
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.
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.
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.
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.
The Estimated Number of Participants
-
Taiwan
46 participants
-
Global
800 participants
