A Phase 2 interventional study of Iparomlimab/Tuvonralimab in Recurrent Ovarian Cancer and Platinum-sensitive Ovarian Cancer, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive iparomlimab/tuvonralimab in combination with carboplatin and nab-paclitaxel administered in 3-week cycles during the induction phase. After completion of induction therapy, participants receive oral olaparib as maintenance therapy according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, completion of 2 years of iparomlimab/tuvonralimab treatment, or other protocol-defined discontinuation criteria.
Drug: Iparomlimab/Tuvonralimab
Iparomlimab/Tuvonralimab administered intravenously in 3-week cycles per protocol
Progression-Free Survival (PFS)
Time from first dose to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University