Actively Recruiting
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Led by Akeso · Updated on 2025-03-12
172
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination therapy using two investigational drugs, AK104 and AK112, along with chemotherapy in women with recurrent ovarian cancer. This Phase 2, open-label, multi-center study focuses on high-grade epithelial ovarian cancer that has returned after prior platinum-based chemotherapy treatments. AK104 targets CTLA-4 and PD-1 proteins, while AK112 targets VEGF and PD-1, both aiming to affect tumor growth and immune response. The study includes multiple groups receiving different combinations of AK104, AK112, and chemotherapy. Some groups receive AK104 every six weeks combined with AK112 every three weeks, while others receive these drugs with chemotherapy administered every three weeks. The treatment schedules are designed to assess how these combinations work together in various dosing regimens. Participants will have their cancer response measured using standard imaging criteria over up to two years. They will be closely monitored for side effects and survival outcomes during this period. The research team will collect tumor tissue samples and assess organ function, as well as track adverse events. The study aims to provide detailed information on the response rate, progression-free survival, duration and time to response, and overall survival in women participating in the trial.
CONDITIONS
Brief Title
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Signed written informed consent form
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically diagnosed high-grade epithelial ovarian cancer that has relapsed after platinum-containing standard chemotherapy
- Recurrence of platinum-sensitive cancer not suitable for platinum therapy after 3 or more lines of therapy, or recurrence of platinum-resistant cancer with 3 or fewer prior therapies
- Measurable disease based on RECIST v1.1
- Ability to provide formalin fixed, paraffin-embedded tumor tissue
- Adequate organ function
- Agreement to use effective contraception during and for 6 months after last study treatment dose for those of reproductive potential
You will not qualify if you...
- Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, sex cord stromal cell tumor
- Presence of central nervous system metastases or carcinomatous meningitis
- Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage
- Other active malignancies within 3 years prior to randomization
- Systemic anti-tumor therapy within 3 weeks prior to randomization
- Prior treatments targeting tumor immunity mechanisms
- Major surgery, open biopsy, or significant trauma within 4 weeks prior to randomization
- Active or potentially recurrent autoimmune disease
- Systemic treatment with high-dose glucocorticoids or immunosuppressants within 14 days prior to randomization
- Use of live vaccines within 4 weeks prior to randomization
- Known immunodeficiencies including HIV infection
- History of allogeneic organ or stem cell transplantation
- History of interstitial lung disease or non-infectious pneumonitis
- Serious infections requiring hospitalization
- Active infections requiring systemic therapy
- Active hepatitis B or C
- Active inflammatory bowel diseases or diverticulitis
- Clinically significant cardio-cerebrovascular disease
- Unresolved toxicities from prior anticancer therapy
- History of severe hypersensitivity to monoclonal antibodies
- Pregnant or lactating women
- Any condition posing risk with study drug
- Known allergy or contraindications to chemotherapy agents for designated cohorts
- Known allergy or contraindications to VEGF monoclonal antibodies or related safety concerns for AK112 cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive combination therapy with AK104, AK112, and chemotherapy according to their assigned cohort.
Visits every 3 or 6 weeks depending on assigned treatment schedule
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
T
Ting Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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