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Recurrent Cervical CancerPhase 2NCT04380805

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer

A Phase 2 study testing AK104 in people with Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Akeso at 25 sites in 3 countries.

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 Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
AK104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
25 sitesin 3 countries
Study dates
15 Jul 2020to 31 Jan 2023
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
  • Women aged ≥18 years at the time of study entry.
  • Subjects must have histologically or cytologically confirmed recurrent or metastatic squamous carcinoma or adenosquamous carcinoma of the cervix, and meet the following criteria: disease progression confirmed by radiologic imaging during or following prior platinum based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer; No more than 2 prior systemic therapies in the recurrent or metastatic setting.
  • Subjects must have measurable lesions according to RECIST v1.1. The presence of measurable lesions must be confirmed by the IRRC. A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.
  • Available archived tumor tissue sample - block or a minimum of 10 unstained slides of formalin fixed paraffin embedded [FFPE] tissues - preferably from the most recent biopsy of a tumor lesion collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Adequate organ function.

Who cannot join

  • Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
  • Histological types of cervical cancer other than squamous carcinoma and adeno-squamous carcinoma (eg, adenocarcinoma, small cell carcinoma, clear cell carcinoma, sarcoma, etc).
  • Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal cell skin cancer, or carcinoma in situ of the breast.
  • Brain/central nervous system (CNS) metastases.
  • Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent
  • Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product.
Show all 20Show fewer
  • Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
  • Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).
  • Active or prior documented autoimmune disease that may relapse.
  • History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
  • Patients with clinically significant cardio-cerebrovascular disease.
  • 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 eligibility criteria with the exception of toxicities not considered a safety risk.
  • History of severe hypersensitivity reactions to other mAbs.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • Known allergy or reaction to any component of the AK104 formulation.
  • Receipt of the following treatments or procedures: anticancer small molecule targeted agent within 2 weeks, radiation therapy within 2 weeks, other anticancer therapy within 4 weeks, any major surgery within 4 weeks, any other investigational product or procedure within 4 weeks, or agents with immunomodulatory effect within 2 weeks prior to the first dose of investigational product.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily doses of prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of investigational product.
  • Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational product.
  • Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States19 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005-2380

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Chattanooga's Program In Women's Oncology

    Chattanooga, Tennessee, 37403

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Lyndon B. Johnson Hospital (MD Anderson)

    Houston, Texas, 77026

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Tennessee Oncology - Centennial Clinic

    Nashville, Tennessee, 37203

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

  • Womens Cancer Research Foundation

    Newport Beach, California, 92663

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • BRCR Medical Center

    Plantation, Florida, 33322

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Pacific Gynecology Specialists, P. C.

    Seattle, Washington, 98104

  • Maryland Oncology Hematology (Plum Orchard)

    Silver Spring, Maryland, 20904

  • Texas Oncology (Woodlands)

    The Woodlands, Texas, 77380

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

Other trials in United States

Australia5 sites

  • Ashford Cancer Centre Research

    Adelaide

  • Blacktown Hospital

    Blacktown

  • ICON Cancer Centre

    Brisbane

  • Monash Health

    Clayton, Victoria

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

Other trials in Australia

New Zealand1 site

  • Auckland City Hospital

    Grafton, Auckland

Other trials in New Zealand

About this study

Official title: A Phase 2, Multicenter, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects With Recurrent or Metastatic Cervical Cancer

This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.

Being tested
AK104
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.

  • AK104Biological

    All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.

Study groups in NCT04380805
Study groupRoleWhat they receive
AK104ExperimentalAK104 monotherapy
Receives: Biological: AK104

What is being measured

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

  1. Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC)

    Measured: Up to 2 years

Secondary outcomes (7)

  1. ORR assessed by Investigator

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

    Measured: Up to 2 years

  2. 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

  3. 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

  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. Number of participants with adverse events (AEs)

    Measured: From the time of informed consent signed through 30 days after the last dose, up to 2 years

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

    Measured: From first dosing date of AK104 through 30 days post last dose of AK104, up to 2 years

  7. Number of subjects who develop detectable anti-drug antibodies

    Measured: From first dosing date of AK104 through 90 days post last dose of AK104, up to 2 years

Timeline

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

  1. First posted8 May 2020
  2. Study start15 Jul 2020
  3. Primary completion22 Dec 2022
  4. Study completion31 Jan 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380805
Sponsor's protocol ID
AK104-201-AU
Status last verified
Feb 2025
First submitted
1 May 2020
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104 in people with Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Akeso at 25 sites in 3 countries.

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 8 inclusion and 20 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Australia, New Zealand. 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?

Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC) (time frame: Up to 2 years). 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 NCT04380805.

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 28 Feb 2025.

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