Combining AK104 with chemotherapy for advanced ovarian cancer treatment
Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
This study is testing if combining a new antibody treatment called AK104 with chemotherapy can help women with advanced ovarian cancer who can't have surgery feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Hunan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05430906 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of AK104, a bispecific antibody targeting PD-1 and CTLA-4, when combined with chemotherapy as a neoadjuvant treatment for advanced ovarian cancer. The approach is based on previous findings suggesting that this combination may enhance treatment outcomes while maintaining a manageable safety profile. Eligible participants include women aged 18 to 75 with advanced ovarian cancer who cannot undergo primary surgery. The study aims to assess the response of measurable lesions to this treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with advanced FIGO stage III to IV ovarian cancer who are recommended for neoadjuvant chemotherapy.
Not a fit: Patients with non-epithelial ovarian tumors, other active malignancies, or uncontrolled serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for women with advanced ovarian cancer who are not candidates for immediate surgery.
How similar studies have performed: Previous studies have indicated potential success with similar immunotherapy and chemotherapy combinations, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: - 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended. 4. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function. Key Exclusion Criteria: * 1. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary. 2. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5. Presence of other uncontrolled serious medical conditions.
Where this trial is running
Changsha, Hunan
- Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Jie Tang
- Email: tangjie@hnca.org.cn
- Phone: +8615274836636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.