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Active, not recruitingNCT04982237Updated Nov 19, 2025

A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

A Phase 3 interventional study of AK104 and paclitaxel in Cervical Cancer, sponsored by Akeso. Active, not recruiting at 5 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Akeso · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
445
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

02

Conditions studied

  • Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 445 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
445 participants (actual)

Study arms

  • Experimental
    AK104+chemotherapy± bevacizumab

    AK104 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

    Biological: AK104 · Drug: paclitaxel · Drug: carboplatin · Drug: cisplatin · Drug: bevacizumab

  • Placebo comparator
    Placebo+chemotherapy± bevacizumab

    Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

    Drug: paclitaxel · Drug: carboplatin · Drug: cisplatin · Drug: bevacizumab · Drug: Placebo

Interventions

  • BiologicalAK104

    IV infusion

  • Drugpaclitaxel

    IV infusion

  • Drugcarboplatin

    iv infusion

  • Drugcisplatin

    iv infusion

  • Drugbevacizumab

    iv infusion

  • DrugPlacebo

    iv infusion

06

What researchers measure

Primary outcomes

  1. progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1

    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

    Time frame: Up to approximately 2 years

  2. overall survival (OS)

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

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

    Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria

    Time frame: Up to approximately 2 years

  2. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

    Time frame: Up to approximately 2 years

  3. Time to Response（TTR Per RECIST 1.1 as Assessed by BICR

    Time frame: Up to approximately 2 years

  4. AE

    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

    Time frame: Up to approximately 2 years

  5. Observed concentrations of AK104

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

    Time frame: From first dose of AK104 through 90 days after last dose of AK104

  6. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)

    Time frame: From first dose of AK104 through 90 days after last dose of AK104

07

Study locations

5 sites
  • Women's Hospital School Of Medicine Zhejiang University
    Hangzhou, China
  • Zhejiang Cancer Hospital
    Hangzhou, China
  • Anhui Provincial Hospital
    Hefei, China
  • The Second Affiliated Hospital,Anhui Medical University
    Hefei, China
  • Fudan University Shanghai Cancer Center
    Shanghai, 200032, China
08

References and documents

Publications

  • Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16. PubMed 39426385 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04982237
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Jul 29, 2021
Start date
Aug 27, 2021
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Nov 19, 2025

Study contacts

Xiaohua Wu, MD
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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