Can an immunotherapy boost give advanced cervical cancer patients more time?
NCT ID NCT05798819
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 424 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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