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Persistent, Recurrent, or Metastatic Cervical CancerPhase 3NCT05798819

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

A Phase 3 study testing GLS-010, paclitaxel and cisplatin in people with Persistent, Recurrent, or Metastatic Cervical Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
GLS-010, paclitaxel and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
424 participants
Where
1 siteChina
Study dates
20 Apr 2023to 1 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai Municipality

    Xiaohua Wu, MD, 8621-6417 5590, wu.xh@fudan.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
GLS-010, Placebo, paclitaxel, cisplatin, carboplatin
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05798819
Study groupRoleWhat they receive
GLS-010+chemotherapy± bevacizumabExperimentalGLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Receives: Drug: GLS-010; Drug: Placebo; Drug: paclitaxel; Drug: cisplatin; Drug: carboplatin
Placebo+chemotherapy± bevacizumabPlacebo comparatorPlacebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Receives: Drug: Placebo; Drug: paclitaxel; Drug: cisplatin; Drug: carboplatin; Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival (OS)

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

    Measured: Up to 2 years

Secondary outcomes (7)

  1. 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.

    Measured: Up to 2 years

  2. Objective Response Rate (ORR)

    Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

  4. Disease Control Rate (DCR)

    DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.

    Measured: Up to 2 years

  5. 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.

    Measured: Up to 2 years

  6. 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

    Measured: From the time of signed informed consent to 90 days after end of treatment.

  7. Quality of life (QoL)

    EORTC QLQ-C30 will be used.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start20 Apr 2023
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798819
Sponsor's protocol ID
GLS-010-32
Status last verified
Sep 2026
First submitted
26 Dec 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GLS-010, paclitaxel and cisplatin in people with Persistent, Recurrent, or Metastatic Cervical Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (OS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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