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AzTrials

Cervical CancerPhase 3NCT04982237

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

A Phase 3 study testing AK104, paclitaxel and carboplatin in people with Cervical Cancer, run by Akeso at 5 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
AK104, paclitaxel and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
445 participants
Where
5 sitesChina
Study dates
27 Aug 2021to 30 Dec 2025
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

  • signs the written informed consent form.
  • Women aged ≥ 18 and ≤ 75 years.
  • ECOG of 0 or 1.
  • Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.
  • The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;
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  • No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.
  • 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.
  • All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.
  • Subjects must have adequate organ function as assessed in the laboratory tests.
  • 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.

Who cannot join

  • Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
  • Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator.
  • Presence of nervous system (CNS) metastases or carcinomatous meningitis;
  • Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Patients with other active malignancies within 3 years prior to randomization.
  • Patients who have received other prior chemotherapeutic agents.
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  • 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).
  • Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
  • Active or potentially recurrent autoimmune disease.
  • 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;
  • Use of live vaccines within 4 weeks prior to randomization.
  • Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Known history of interstitial lung disease or non-infectious pneumonitis; unless induced by radiation therapies.
  • Serious infections requiring hospitalization.
  • Presence of active infection requiring systemic therapy.
  • Subjects with active hepatitis B and active viral hepatitis C.
  • Active or documented inflammatory bowel diseases, active diverticulitis.
  • Subjects with known history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Known any contraindication to cisplatin/carboplatin, paclitaxel or allergy to any of their ingredients.
  • Pregnant or lactating women.
  • Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • The Second Affiliated Hospital,Anhui Medical University

    Hefei

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: 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

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

Conditions
Cervical Cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

Study groups in NCT04982237
Study groupRoleWhat they receive
AK104+chemotherapy± bevacizumabExperimentalAK104 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Receives: Biological: AK104; Drug: paclitaxel; Drug: carboplatin; Drug: cisplatin; Drug: bevacizumab
Placebo+chemotherapy± bevacizumabPlacebo comparatorPlacebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
Receives: Drug: paclitaxel; Drug: carboplatin; Drug: cisplatin; Drug: bevacizumab; Drug: Placebo

What is being measured

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

  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

    Measured: Up to approximately 2 years

  2. overall survival (OS)

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

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  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

    Measured: 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.

    Measured: Up to approximately 2 years

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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: From first dose of AK104 through 90 days after last dose of AK104

Timeline

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

  1. First posted29 Jul 2021
  2. Study start27 Aug 2021
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (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
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982237
Sponsor's protocol ID
AK104-303
Status last verified
Nov 2025
First submitted
21 Jul 2021
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK104, paclitaxel and carboplatin in people with Cervical Cancer, run by Akeso at 5 sites 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1 (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. 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 NCT04982237, which also lists 1 linked publication.

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 19 Nov 2025.

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