NCT06509971

A Study of QL1706 (an Anti-PD-1/CTLA-4 Combined Antibody) Combined With Albumin-bound Paclitaxel and Bevacizumab in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

* Major objectives To evaluate the efficacy of QL1706 combined with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer. * Secondary Purpose To evaluate the safety of QL1706 in combination with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer. Exploratory analysis of the association between the efficacy of the combination regimen and biomarkers.

Detailed description

The efficacy of chemotherapy combined with anti-angiogenic agents in the treatment of platinum-resistant recurrent ovarian cancer has been demonstrated in clinical studies, and QL1706 acts as a bi-functional combination antibody that blocks both PD-1 and CTLA-4, in other cancer trials that have been conducted, it is expected that better efficacy and adverse event rates comparable to those of anti-PD-1 mabs and anti-CTLA-4 mabs will be achieved with combination chemotherapy and anti-angiogenic drugs, it may be possible to obtain better anti-tumor effects in platinum-resistant recurrent ovarian cancer patients.

Conditions

• Platinum-resistant Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	QL1706	The Order of Drug Administration was: QL1706→ bevacizumab → albumin-binding paclitaxel, and each drug was administered at least 30 minutes apart. QL1706: 5 mg/kg Q3W. The infusion time was 30 minutes + 5 minutes. No dose adjustment was allowed for QL1706 during treatment, but delayed administration was allowed, with a delay of no more than 4 weeks from the previous dose. Albumin-binding paclitaxel: 260 mg/m 2 Q3W, IV, for 30 min + 5 min. During treatment, albumin-binding paclitaxel allows for dose adjustments. Bevacizumab: 15 mg/kg Q3 W, iv. The first infusion should last 90 minutes. If the first infusion was well tolerated, the second infusion could be shortened to 60 minutes. If the patient is also well-tolerated for a 60-minute infusion, then all subsequent infusions can be completed in 30 minutes, no dose adjustment is allowed for bevacizumab.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2024-07-19
• Last updated: 2024-07-19