Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:17 AM
Study NCT ID:
NCT07454018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iparomlimab/Tuvonralimab + Standard Chemotherapy and Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
A Single-Arm, Exploratory, Multicenter Study Evaluating Iparomlimab/Tuvonralimab Combined With Standard Chemotherapy Followed by Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: