New drug cocktail aims to fight advanced cervical cancer
NCT ID NCT04982237
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial is testing whether adding the immunotherapy AK104 to standard chemotherapy (with or without bevacizumab) helps people with advanced cervical cancer that cannot be cured by surgery or radiation. About 445 participants will receive either the drug combo or a placebo. The main goals are to see if the treatment slows cancer growth and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK104 (a type of immunotherapy) plus chemotherapy (paclitaxel, carboplatin, or cisplatin) with or without bevacizumab
- What this could lead to
- If successful, this could offer a new first-line treatment option that helps people with advanced cervical cancer live longer and delay disease progression.
- What could go wrong
- This is an early-stage Phase 3 trial, so results are not yet confirmed. The treatment may not work better than standard care, and side effects from the combination therapy could be significant.
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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445 people
The number who actually took part.
- Started
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Aug 2021
- Expected to finish
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Dec 2025
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. signs the written informed consent form. 2. Women aged ≥ 18 and ≤ 75 years. 3. ECOG of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy. 1. The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 2. No prior systemic therapy for persistent, recurrent or metastatic (\[FIGO\] Stage IVB) disease. 6. At least one measurable tumor lesion per RECIST v1.1; lesions at sites 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. 7. All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy. 8. Subjects must have adequate organ function as assessed in the laboratory tests. 9. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug. Exclusion Criteria: 1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc. 2. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator. 3. Presence of nervous system (CNS) metastases or carcinomatous meningitis; 4. Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. Patients with other active malignancies within 3 years prior to randomization. 6. Patients who have received other prior chemotherapeutic agents. 7. Any prior treatments targeting the mechanism of tumor immunity, such as anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc). 8. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study. 9. Active or potentially recurrent autoimmune disease. 10. Subjects who require systemic treatment with glucocorticoid (\> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization; 11. Use of live vaccines within 4 weeks prior to randomization. 12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies. 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. Known history of interstitial lung disease or non-infectious pneumonitis; unless induced by radiation therapies. 15. Serious infections requiring hospitalization. 16. Presence of active infection requiring systemic therapy. 17. Subjects with active hepatitis B and active viral hepatitis C. 18. Active or documented inflammatory bowel diseases, active diverticulitis. 19. Subjects with known history of severe hypersensitivity reactions to other monoclonal antibodies. 20. Known any contraindication to cisplatin/carboplatin, paclitaxel or allergy to any of their ingredients. 21. Pregnant or lactating women. 22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
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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.
Contacts and locations
Locations
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Anhui Provincial Hospital
Hefei, China
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Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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The Second Affiliated Hospital,Anhui Medical University
Hefei, China
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Women's Hospital School Of Medicine Zhejiang University
Hangzhou, China
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Zhejiang Cancer Hospital
Hangzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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