search
Back to results

A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Primary Purpose

Persistent, Recurrent, or Metastatic Cervical Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
GLS-010
Placebo
paclitaxel
cisplatin
carboplatin
bevacizumab
Sponsored by
Guangzhou Gloria Biosciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent, Recurrent, or Metastatic Cervical Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLS-010+chemotherapy± bevacizumab

Placebo+chemotherapy± bevacizumab

Arm Description

GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Outcomes

Primary Outcome Measures

overall survival (OS)
OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

progression-free survival (PFS)
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.
Objective Response Rate (ORR)
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
Duration of Response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Disease Control Rate (DCR)
DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.
Time to Response(TTR)
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.
Number of subjects with adverse events (AEs)
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
Quality of life (QoL)
EORTC QLQ-C30 will be used.

Full Information

First Posted
December 26, 2022
Last Updated
April 4, 2023
Sponsor
Guangzhou Gloria Biosciences Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05798819
Brief Title
A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Gloria Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent, Recurrent, or Metastatic Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLS-010+chemotherapy± bevacizumab
Arm Type
Experimental
Arm Description
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Arm Title
Placebo+chemotherapy± bevacizumab
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Intervention Type
Drug
Intervention Name(s)
GLS-010
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
overall survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
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.
Time Frame
Up to 2 years
Title
Objective Response Rate (ORR)
Description
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Description
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time Frame
Up to 2 years
Title
Disease Control Rate (DCR)
Description
DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.
Time Frame
Up to 2 years
Title
Time to Response(TTR)
Description
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.
Time Frame
Up to 2 years
Title
Number of subjects with adverse events (AEs)
Description
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
Time Frame
From the time of signed informed consent to 90 days after end of treatment.
Title
Quality of life (QoL)
Description
EORTC QLQ-C30 will be used.
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

We'll reach out to this number within 24 hrs