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CarcinomasPhase 2NCT05063916

Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

A Phase 2 study testing AK104 in people with Carcinomas and Cervix Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

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 Phase 2, single center, open-label, single-arm study designed to evaluate the efficacy, safety, tolerability, and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic high grade neuroendocrine cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinomas, Cervix Cancer, Cervical Cancer
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
18 participants
Where
1 siteUnited States
Study dates
28 Feb 2022to 1 Aug 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written and signed informed consent.
  • Age ≥ 18 years at time of study entry
  • Histologically or cytologically confirmed recurrent or metastatic high grade neuroendocrine carcinoma of the cervix with disease progression confirmed by radiologic imaging during or following prior platinum-based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer
  • Received no more than 2 prior systemic therapies in the recurrent or metastatic setting
  • Not eligible for surgery and/or radiation as treatment options for recurrent disease
  • Measurable lesions according to RECIST v1.1. (A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.)
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  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
  • Adequate organ function as determined by:
  • Hematological criteria (subjects should not have received either growth factor support or recent transfusions within 7 days prior to starting study treatment):
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L (1,500/mm3)
  • Platelet count ≥100 × 109/L (100,000/mm3)
  • Hemoglobin ≥9.0 g/dL (90 g/L)
  • Renal criteria:
  • Serum creatinine <1.5 × upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 by Cockcroft-Gault formula
  • Hepatic criteria:
  • AST and ALT ≤2.5 × ULN; for subjects with liver metastasis, AST/ALT can be
  • ≤5 × ULN
  • Serum total bilirubin (TBL) ≤1.5 × ULN; for subjects with documented/suspected Gilbert's disease, TBL <3 × ULN
  • One of the following conditions applies:
  • Is a woman of childbearing potential (WOCBP) who is sexually active with a nonsterilized male partner must have a negative pregnancy test at the Screening visit (within 3 days prior to the first dose of the investigational product [Cycle 1 Day 1]), should not be lactating, and must agree to use 1 methods of contraception b. Is a woman of nonchildbearing potential
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

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 high grade neuroendocrine caricnoma (e.g.
  • squamous carcinoma, adenocaricnoma, adeno-squamous 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: Subjects with suspected brain metastases should have a computed tomography (CT)/magnetic resonance imaging (MRI) scan of the brain to confirm the absence of brain/CNS metastases prior to enrollment.
  • Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent
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  • Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product.
  • 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. NOTE: Subjects with controlled type 1 diabetes mellitus, thyroiditis in euthyroid state or hypothyroidism well managed by hormone replacement therapy (HRT), or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis) are eligible.
  • History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
  • Clinically significant cardio-cerebrovascular disease:
  • Myocardial infarction, unstable angina, pulmonary embolism, stroke, or any other significant cardiovascular or cerebrovascular accident within 6 months prior to the first dose of investigational product.
  • New York Heart Association Grade III or greater congestive heart failure within 6 months prior to the first dose of investigational product.
  • Serious cardiac arrhythmia such as ventricular arrhythmia requiring medication or second- or third-degree atrioventricular block. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (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 (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
  • 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 prior to the first dose of investigational product.
  • Radiation therapy within 2 weeks prior to the first dose of investigational product.
  • Other anticancer therapy (e.g., chemotherapy, radiotherapy, anticancer mAbs, etc) within 4 weeks prior to the first dose of investigational product.
  • Any major surgery (e.g., laparotomy, thoracotomy, removal of organ[s]) within 4 weeks prior to the first dose of investigational product.
  • Any other nonapproved investigational product or procedure within 4 weeks prior to the first dose of investigational product.
  • Agents with immunomodulatory effect (e.g., thymosin, IFN, interleukin) 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. The following are exceptions to this criterion:
  • Corticosteroids used as adrenal replacement (<10 mg daily prednisone or equivalent).
  • Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption.
  • Corticosteroids used as pretreatment medication for hypersensitivity reactions (e.g., CT scan premedication).
  • Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational product. Note: Seasonal vaccines for influenza which are generally inactivated are allowed.
  • Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (e.g., 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

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

This is a Phase 2, single center, open-label, single-arm study designed to evaluate the efficacy, safety, tolerability, and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic high grade neuroendocrine cervical cancer.

Read the detailed description

Primary Objective:

-To estimate progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix.

Secondary Objective:

  • To evaluate the efficacy of AK104 monotherapy in terms of DoR and DCR in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix.
  • To evaluate the efficacy of AK104 monotherapy in terms of ORR in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix.
  • To evaluate the safety and tolerability profile of AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix.
  • To determine presence of HPV cell free DNA and if levels of HPV cell free DNA may serve as a surrogate for response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix
Being tested
AK104
Medical subject headings
Carcinoma, Uterine Cervical Neoplasms

What participants receive

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

  • AK104Drug

    Also called Cadonilimab

    Given By IV

Study groups in NCT05063916
Study groupRoleWhat they receive
AK104Experimentalcadonilimab) can help to control neuroendocrine cervical cancer that is recurrent (has come back after treatment) or metastatic (has spread).
Receives: Drug: AK104

What is being measured

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

  1. To establish the progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix

    Measured: (up to 6 months) through study completion, an average of 1 year

Timeline

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

  1. First posted1 Oct 2021
  2. Study start28 Feb 2022
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05063916
Sponsor's protocol ID
2021-0585
Other IDs
NCI-2021-10701
Status last verified
Aug 2026
First submitted
15 Sep 2021
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104 in people with Carcinomas and Cervix Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

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 21 inclusion and 33 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

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?

To establish the progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix (time frame: (up to 6 months) through study completion, an average of 1 year). 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 NCT05063916.

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 12 Aug 2026.

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