A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer (AK104-305)

  • STATUS
    Recruiting
  • End date
    May 14, 2029
  • participants needed
    636
  • sponsor
    Akeso
Updated on 4 October 2022

Summary

This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer

Details
Condition Locally Advanced Cervical Carcinoma
Treatment cisplatin, Placebo, EBRT, AK104, BT
Clinical Study IdentifierNCT05235516
SponsorAkeso
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

signs the written informed consent form
ECOG 0-1
Life expectancy ≥ 3 months
The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma
Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
At least one measurable tumor lesion per RECIST v1.1
Adequate organ function as assessed in the laboratory tests

Exclusion Criteria

Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc
FIGO 2018 IVB
Subjects who had previously undergone total hysterectomy
Subjects who cannot receive brachytherapy
Subjects with other active malignancies within 2 years prior to randomization
Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc)
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
Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
Use of live vaccines within 4 weeks prior to randomization
Active or potentially recurrent autoimmune disease
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
Pregnant or lactating women
Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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