Clinical trial NCT05798819: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Persistent, Recurrent, or Metastatic Cervical Cancer
Lead sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 424
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall survival (OS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Time to Response（TTR）
timeFrame: Up to 2 years
measure: Number of subjects with adverse events (AEs)
timeFrame: From the time of signed informed consent to 90 days after end of treatment.
measure: Quality of life (QoL)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
state: Shanghai
Study officials:
References: