Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer (NCT05824481) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer
China32 participantsStarted 2023-05-08
Plain-language summary
This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with lenvatinib in patients with advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus lenvatinib.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
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
. Signed Informed Consent Form (ICF).
. Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has documented evidence of metastatic or recurrent EC which is not amenable to curative treatment with surgery and/or radiation therapy.
. Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.
. Age ≥ 18 years and ≤ 75 years.
. Has measurable disease per RECIST v1.1.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Life expectancy exceeds 3 months.
. Has adequate organ function as defined by the following criteria:
Exclusion criteria
. Histologic types of carcinoma other than endometrial carcinoma.
. Known or suspected allergy to any of study drugs.
. Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or small molecule anti-angiogenic agent.
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
Maximum tolerated dose (MTD)
Timeframe: the first 21 days of treatment
2
Recommended Phase 2 dose (RP2D)
Timeframe: the first 21 days of treatment
3
Response Rate (ORR)
Timeframe: from the first drug administration up to two years
. Has an active autoimmune disease requiring systemic therapy (i.e., with use of disease modifying drugs, corticosteroids or immunosuppressive drugs) in past 2 years. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
. Concurrent medical condition requiring the use of systemic steroid therapy (dose \>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of study intervention.
. Has received anti-tumor treatment within 28 days, including but not limited to chemotherapy and radiotherapy or targeted therapy.
. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with exception of alopecia and anemia.
. Has an active infection requiring systemic therapy.