This is a prospective, open-label, single-arm, multicenter exploratory clinical study designed to evaluate the efficacy and safety of iparomlimab/tuvonralimab (QL1706), a bispecific antibody targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), in combination with standard platinum-based chemotherapy followed by olaparib in patients with platinum-sensitive recurrent epithelial ovarian cancer.
Eligible participants are women aged 18-75 years with histologically or cytologically confirmed non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma) who experience first or second recurrence at least 6 months after the last platinum-containing chemotherapy, have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and are deemed not suitable for surgery by the investigator.
The study consists of a screening period (up to 28 days), a treatment period, and a follow-up period. Treatment is administered in 3-week cycles and continues until disease progression, unacceptable toxicity, withdrawal of consent, loss of clinical benefit per investigator judgment, completion of 2 years of iparomlimab/tuvonralimab (QL1706), or other protocol-defined reasons. Safety assessments are performed regularly during treatment; a safety follow-up visit is conducted 30 (±7) days after the last dose, and survival follow-up is performed every 2 months thereafter. The primary objective is to explore the antitumor efficacy of the regimen in platinum-sensitive recurrent epithelial ovarian cancer, and the secondary objective is to characterize the safety profile of the combination strategy.
Female participants aged 18 to 75 years. Voluntarily provide written informed consent and able to comply with protocol requirements.
Histologically and/or cytologically confirmed recurrent non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma).
First or second recurrence after standard platinum-containing chemotherapy, with recurrence diagnosed ≥ 6 months after the last dose of platinum-containing chemotherapy (platinum-sensitive recurrence).
Not suitable for surgery as assessed by the investigator.
Any active autoimmune disease or history of autoimmune disease.
Mucinous ovarian cancer, sex cord-stromal tumors, or other non-eligible histologic types.
Uncontrolled pleural effusion, pericardial effusion, or ascites that cannot be stabilized despite repeated drainage or other interventions per investigator judgment.
Other active malignancy within 2 years prior to first dose.