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 range18 Years – 75 Years
SexFEMALE
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.
✕. 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.
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
✕. 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.