- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798819
A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
April 4, 2023 updated by: Guangzhou Gloria Biosciences Co., Ltd.
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled phase III study,aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
Study Type
Interventional
Enrollment (Anticipated)
424
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Fudan University Shanghai Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Signed the informed consent form.
- Women aged ≥ 18 and ≤ 75 years.
- ECOG of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
- No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease,not amenable to curative surgery or concurrent chemoradiotherapy.
- At least one measurable tumor lesion per RECIST v1.1; lesions previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.
- Subjects must have adequate organ function.
- Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. Female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 6 months after the last dose of study drug.
Exclusion Criteria:
- Patients with the opportunity to be cured by surgery and radiotherapy.
- Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.
- Active central nervous system (CNS) metastasis.
- Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.
- Has an active autoimmune disease that has required systemic treatment.
- With active serious infections.
- Subjects with HIV infection ,active hepatitis B virus infection, active hepatitis C virus infection,active tuberculosis infection,active syphilis .
- Has not recovered adequately from toxicity and/or complications from surgery prior to randomization.
- . .
- Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab.
- Have received any investigational treatment in other clinical trials within 4 weeks prior to randomization.
- Pregnant or lactating women,or women may become pregnant during treatment.
- Has had an allogeneic tissue/solid organ/ hematopoietic stem cells transplant.
- History of nervous system and mental disease. History of drug abuse.
- The patient is not suitable to participate the study in the opinion of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
|
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
|
Experimental: GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
|
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: Up to 2 years
|
OS is defined as the time from randomization to death due to any cause.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival (PFS)
Time Frame: Up to 2 years
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Per RECIST 1.1.
|
Up to 2 years
|
Objective Response Rate (ORR)
Time Frame: Up to 2 years
|
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
|
Up to 2 years
|
Duration of Response (DOR)
Time Frame: Up to 2 years
|
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
|
Up to 2 years
|
Disease Control Rate (DCR)
Time Frame: Up to 2 years
|
DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.
|
Up to 2 years
|
Time to Response(TTR)
Time Frame: Up to 2 years
|
TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on RECIST v1.1 criteria.
|
Up to 2 years
|
Number of subjects with adverse events (AEs)
Time Frame: From the time of signed informed consent to 90 days after end of treatment.
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
|
From the time of signed informed consent to 90 days after end of treatment.
|
Quality of life (QoL)
Time Frame: Up to 2 years
|
EORTC QLQ-C30 will be used.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Disease Attributes
- Uterine Cervical Neoplasms
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- GLS-010-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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