Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the C… (NCT05063916) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix
United States18 participantsStarted 2022-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: (up to 6 months) through study completion, an average of 1 year
. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
. Adequate organ function as determined by:
Exclusion criteria
. 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.
. 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
. 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).