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NOT YET RECRUITING
NCT07407452
PHASE2

Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer

Sponsor: Jiangsu Cancer Institute & Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status: Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + paclitaxel (175 mg/m², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)/cisplatin (75 mg/m², Q3W, D1). Planned enrollment: 30 patients. Cohort 2: ECOG PS 2, BRCA1/2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg/m², Q3W, D1). Planned enrollment: 20 patients. Neoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR/PR/SD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.

Official title: A Prospective, Open-label, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-02-01

Completion Date

2028-12-31

Last Updated

2026-02-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Iparomlimab and Tuvonralimab (QL1706)Injection

5 mg/kg, Q3W, D1

DRUG

paclitaxel

175 mg/m², Q3W, D1

DRUG

carboplatin

AUC 5-6, Q3W, D1

DRUG

Cisplatin

75 mg/m², Q3W, D1

DRUG

Olaparib

300 mg, for 2-3 cycles, bid

DRUG

Cisplatin

intraperitoneal perfusion, 75 mg/m², Q3W, D1

Locations (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China