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

NCT ID: NCT05798819

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-01

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.

Conditions

Persistent, Recurrent, or Metastatic Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLS-010+chemotherapy± bevacizumab

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

Group Type: EXPERIMENTAL

GLS-010

Intervention Type: DRUG

IV infusion

Placebo

Intervention Type: DRUG

IV infusion

paclitaxel

Intervention Type: DRUG

IV infusion

cisplatin

Intervention Type: DRUG

IV infusion

carboplatin

Intervention Type: DRUG

IV infusion

Placebo+chemotherapy± bevacizumab

Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

paclitaxel

Intervention Type: DRUG

IV infusion

cisplatin

Intervention Type: DRUG

IV infusion

carboplatin

Intervention Type: DRUG

IV infusion

bevacizumab

Intervention Type: DRUG

IV infusion

Interventions

GLS-010

IV infusion

Intervention Type: DRUG

Placebo

IV infusion

Intervention Type: DRUG

paclitaxel

IV infusion

Intervention Type: DRUG

cisplatin

IV infusion

Intervention Type: DRUG

carboplatin

IV infusion

Intervention Type: DRUG

bevacizumab

IV infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Gloria Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

GLS-010-32

Identifier Type: -

Identifier Source: org_study_id