NCT06917092

QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer

A Phase II Study to Evaluate the Efficacy and Safety of QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multicenter Phase II study evaluating the efficacy and safety of QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who progressed after prior anti-PD-1/L1 therapy.

Detailed description

This prospective, single-arm, multicenter Phase II study evaluates the efficacy and safety of QL1706 plus physician's choice chemotherapy (with or without bevacizumab) in patients with advanced recurrent or metastatic endometrial cancer refractory to prior PD-1/L1 inhibitor therapy. The study consists of three phases: screening, treatment, and post-treatment follow-up, with continuous safety monitoring throughout. Eligible patients had confirmed disease progression following previous PD-1/L1 inhibitor treatment. Participants received QL1706 combined with physician's choice chemotherapy, with or without bevacizumab. All participants will undergo post-treatment safety monitoring and survival follow-up after treatment completion. For patients who discontinue treatment for reasons other than disease progression or death, additional tumor progression follow-up will be conducted post-treatment.

Conditions

• Endometrial Adenocarcinoma
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	QL1706 combined with chemotherapy ± Bevacizumab	* Drug: QL1706: 5 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first. * Drug: Chemotherapy: physician's choice chemotherapy for 3-6 cycles. * Drug: Bevacizumab (optional): 15 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-30
• Completion: 2030-04-30
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: China