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Can an immunotherapy boost give advanced cervical cancer patients more time?

NCT ID NCT05798819

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether adding an experimental immunotherapy drug called GLS-010 to standard platinum-based chemotherapy, with or without bevacizumab, helps women with persistent, recurrent, or metastatic cervical cancer live longer. The trial enrolls about 424 women aged 18 to 75 whose tumors test positive for PD-L1 and who have not received prior systemic treatment for advanced disease. Participants receive either GLS-010 or a placebo alongside chemotherapy, and researchers compare overall survival between the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GLS-010, an experimental immunotherapy drug, added to platinum-based chemotherapy with or without bevacizumab
What this could lead to
If it works, adding GLS-010 to standard chemotherapy could become a new first-line option that helps women with advanced cervical cancer live longer.
What could go wrong
This is a phase III trial, so the approach is still unproven. Adding an immunotherapy can cause immune-related side effects, and the drug may not improve survival compared with chemotherapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 424 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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