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Trial Title:
A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
NCT ID:
NCT05798819
Condition:
Persistent, Recurrent, or Metastatic Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Recurrence
Paclitaxel
Bevacizumab
Carboplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
GLS-010
Description:
IV infusion
Arm group label:
GLS-010+chemotherapy± bevacizumab
Intervention type:
Drug
Intervention name:
Placebo
Description:
IV infusion
Arm group label:
GLS-010+chemotherapy± bevacizumab
Arm group label:
Placebo+chemotherapy± bevacizumab
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
IV infusion
Arm group label:
GLS-010+chemotherapy± bevacizumab
Arm group label:
Placebo+chemotherapy± bevacizumab
Intervention type:
Drug
Intervention name:
cisplatin
Description:
IV infusion
Arm group label:
GLS-010+chemotherapy± bevacizumab
Arm group label:
Placebo+chemotherapy± bevacizumab
Intervention type:
Drug
Intervention name:
carboplatin
Description:
IV infusion
Arm group label:
GLS-010+chemotherapy± bevacizumab
Arm group label:
Placebo+chemotherapy± bevacizumab
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
IV infusion
Arm group label:
Placebo+chemotherapy± bevacizumab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed the informed consent form.
2. Women aged ≥ 18 and ≤ 75 years.
3. ECOG of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The
histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous
cell carcinoma.
6. No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB)
disease,not amenable to curative surgery or concurrent chemoradiotherapy.
7. 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.
8. Subjects must have adequate organ function.
9. 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:
1. Patients with the opportunity to be cured by surgery and radiotherapy.
2. Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant
chemotherapy within 4 weeks prior to randomization.
3. Active central nervous system (CNS) metastasis.
4. 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.
5. Has an active autoimmune disease that has required systemic treatment.
6. With active serious infections.
7. Subjects with HIV infection ,active hepatitis B virus infection, active hepatitis C
virus infection,active tuberculosis infection,active syphilis .
8. Has not recovered adequately from toxicity and/or complications from surgery prior
to randomization.
9. . .
10. Has a contraindication or hypersensitivity to any component of cisplatin,
carboplatin, paclitaxel, or bevacizumab.
11. Have received any investigational treatment in other clinical trials within 4 weeks
prior to randomization.
12. Pregnant or lactating women,or women may become pregnant during treatment.
13. Has had an allogeneic tissue/solid organ/ hematopoietic stem cells transplant.
14. History of nervous system and mental disease. History of drug abuse.
15. The patient is not suitable to participate the study in the opinion of the
investigator.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Hospital
Address:
City:
Shanghai
Country:
China
Start date:
May 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Gloria Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05798819
