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Recurrent or Metastatic Cervical CancerPhase 2NCT04868708

A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer

A Phase 2 study testing AK104, Bevacizumab and Paclitaxel in people with Recurrent or Metastatic Cervical Cancer, run by Akeso at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Recurrent or Metastatic Cervical Cancer
What is being tested?
AK104, Bevacizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesChina
Study dates
1 Apr 2021to 28 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written and signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  • Estimated life expectancy of ≥3 months.
  • Histologically or cytologically confirmed recurrent or metastatic cervical cancer that not appropriate for radical surgical resection and/or radical radiotherapy or chemotherapy.
  • For cohort A and B: The pathological types were squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. No previous systematic treatment for recurrent or metastatic cervical cancer.
  • For cohort C: The pathological types were squamous cell carcinoma or adenosquamous cell carcinoma. Subjects must have received platinum-containing dual-drug chemotherapy combination with bevacizumab during or after the recurrence or metastasis phase and have demonstrated radiologically confirmed disease progression during or after treatment. Subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages.
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  • Subjects must have at least one measurable lesion in accordance with RECIST v1.1.
  • All subjects must provide archived or freshly acquired tumor tissue samples, approximately 5 unstained FFPE pathological slides.
  • Adequate organ function.
  • Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first administration. If having sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must agree to continue using this contraceptive method for 120 days after the last administration.

Who cannot join

  • Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
  • Other active malignancies within 2 years prior to the first administration. Subjects with locally curable tumors that appear to be cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, were not excluded.
  • Have received other study drugs or study devices within 4 weeks prior to the first administration.
  • Is participating in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.
  • Subjects received systemic treatment with either proprietary Chinese drugs with anti-tumor indications or herbal medicines with anti-tumor effects, or immunomodulatory drugs (thymopeptide, interferon, interleukin) within 2 weeks prior to the first administration.
  • Had received the last course of systemic antitumor therapy within 4 weeks prior to the first administration; Underwent major surgery within 3 weeks; Received non-specific immunoregulatory system treatment within 2 weeks; Any herbal or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks.
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  • Have previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies targeting ICOS, CD40, CD137, GITR, and Ox40 targets, etc.), immune cell therapy, etc. Any treatment targeted at the immune mechanism of tumor.
  • Subjects had an active autoimmune disease that required systemic treatment within 2 years prior to the first administration, or an autoimmune disease that was determined by the investigator to be likely to recur or for which treatment was planned.
  • Active or documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal disorders that can seriously affect the administration and absorption of drug.
  • Subjects requiring systemic treatment with glucocorticoids (> 10 mg/ day equivalent dose of prednisone) or other immunosuppressive agents within 14 days prior to the first administration.
  • Known history of Immunodeficiency.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Underwent major surgery or severe trauma within 28 days prior to the first administration; Underwent surgery to improve or reduce the risk of tumor complications within 14 days prior to the first administration; Or have not fully recovered from previous surgery. Significant surgery is planned within 30 days after the first administration (as determined by the investigator).
  • Medical history of gastrointestinal perforation, gastrointestinal fistula, and female reproductive tract fistula within 6 months prior to the first administration; If the perforation or fistula has been treated by excision or repair and the disease has been recovered or remitted as determined by the investigator, admission is allowed.
  • Known history of interstitial lung disease.
  • Known history of active tuberculosis (TB).
  • Serious infections within 4 weeks prior to the first administration, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
  • An active infection requiring systemic therapy.
  • Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <1000 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
  • Known history of testing positive for human immunodeficiency virus (HIV).
  • Metastases of the central nervous system, metastases of pia mater, spinal cord compression, or pia mater disease confirmed by imaging or pathological examination.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Clinically active hemoptysis, active diverticulitis, peritoneal abscess, or gastrointestinal obstruction.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria.
  • Grade ≥2 peripheral nerve disease, defined according to the NCI CTCAE V5.0 standard.
  • Receipt of live or attenuated vaccination within 30 days prior to the first administration, or plan to receive live or attenuated vaccine during the study.
  • Known history of serious hypersensitivity reaction to other monoclonal antibodies.
  • Subjects with known contraindications to cisplatin/carboplatin, paclitaxel and bevacizumab or a history of allergy/hypersensitivity to any of their components (refer to the relevant drug label, not applicable for Cohort C, bevacizumab-related contraindications and allergy to bevacizumab only to Cohort B).

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase II Study of AK104（an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer

This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy.

Being tested
AK104, Bevacizumab, Paclitaxel, Cisplatin or Carboplatin
Keywords
immuno-oncology, an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody, Recurrent or metastatic cervical cancer, PD-1, CTLA-4
Medical subject headings
Recurrence, Uterine Cervical Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

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

  • AK104Biological

    Subjects will receive AK104 intravenously.

  • BevacizumabBiological

    Subjects will receive Bevacizumab intravenously.

  • PaclitaxelDrug

    Also called PTX

    Subjects will receive Paclitaxel intravenously.

  • Cisplatin or CarboplatinDrug

    Also called DDP,CBP

    Subjects will receive Cisplatin or Carboplatin intravenously.

Study groups in NCT04868708
Study groupRoleWhat they receive
AK104+Paclitaxel+Cisplatin/CarboplatinExperimentalAK104 intravenously(IV) every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)
Receives: Biological: AK104; Drug: Paclitaxel; Drug: Cisplatin or Carboplatin
AK104+Bevacizumab+Paclitaxel+Cisplatin/CarboplatinExperimentalAK104 every 3 weeks (Q3W) Bevacizumab 15mg/kg IV every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)
Receives: Biological: AK104; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin or Carboplatin
AK104ExperimentalAK104 IV every 2 weeks (Q2W)
Receives: Biological: AK104

What is being measured

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

  1. AE

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

    Measured: From the time of informed consent signed through 90 days after the last dose of AK104

Secondary outcomes (8)

  1. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: Up to 2 years

  2. Duration of response (DoR)

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  3. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

    Measured: Up to 2 years

  4. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  5. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.

    Measured: Up to 2 years

  6. Minimum observed concentration (Cmin) of AK104 at steady state

    The endpoints for assessment of PK of AK104 include serum concentrations of AK105 at different timepoints after AK104 administration.

    Measured: From first dose of AK104 through 30 days after last dose of AK104

  7. 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 30 days after last dose of AK104

  8. Expression of PD-L1 in tumor tissue samples

    PD-L1 expression will be determined by IHC in the central laboratory.

    Measured: Baseline (Tumor tissue samples must be provided to the research center or central laboratory prior to initial administration)

Timeline

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

  1. First posted3 May 2021
  2. Study start1 Apr 2021
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868708
Sponsor's protocol ID
AK104-210
Status last verified
Feb 2025
First submitted
5 Apr 2021
Last updated
4 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lou H, Cai H, Huang X, Li G, Wang L, Liu F, Qin W, Liu T, Liu W, Wang ZM, Li B, Xia Y, Wang J. Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study. Clin Cancer Res. 2024 Apr 15;30(8):1501-1508. doi: 10.1158/1078-0432.CCR-23-3162.

    PubMed 38372727

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104, Bevacizumab and Paclitaxel in people with Recurrent or Metastatic Cervical Cancer, run by Akeso at 2 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 10 inclusion and 28 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: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AE (time frame: From the time of informed consent signed through 90 days after the last dose of AK104). 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 NCT04868708, 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 4 Mar 2025.

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