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

NCT05798819 | Not Yet Recruiting Phase 3

• 1 other identifier: GLS-010-32
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent, Recurrent, or Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to 2 years

Secondary Outcomes (7)

• progression-free survival (PFS)

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Time to Response（TTR）

  Up to 2 years

Study Arms (2)

GLS-010+chemotherapy± bevacizumab

EXPERIMENTAL

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

Drug: GLS-010; Drug: Placebo; Drug: paclitaxel; Drug: cisplatin; Drug: carboplatin

Placebo+chemotherapy± bevacizumab

PLACEBO COMPARATOR

Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Drug: Placebo; Drug: paclitaxel; Drug: cisplatin; Drug: carboplatin; Drug: bevacizumab

Interventions

GLS-010 DRUG

IV infusion

GLS-010+chemotherapy± bevacizumab

Placebo DRUG

IV infusion

GLS-010+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

paclitaxel DRUG

IV infusion

GLS-010+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

cisplatin DRUG

IV infusion

GLS-010+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

carboplatin DRUG

IV infusion

GLS-010+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

bevacizumab DRUG

IV infusion

Placebo+chemotherapy± bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Gloria Biosciences Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

zimberelimab; Paclitaxel; Cisplatin; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: April 5, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)