NCT06882447

A Study of QL1706 Combined with Nine HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

A Prospective, Single-center, Single-arm, Phase II Study of QL1706 Combined with Nine价HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The study medications were used as follows: 1 cycle every 21 days (3 weeks) of the following regimen. Test drug: QL1706, HPV 9-valent vaccine QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on Day 1 of each cycle and every 3 weeks (21 days). Treatment will continue until loss of clinical benefit, occurrence of intolerable toxicity, patient or physician decision to discontinue treatment, death of the patient receiving the experimental treatment, or completion of 2 years of dosing (35 dosing cycles), withdrawal of informed consent by the subject, pregnancy of the subject, noncompliance with protocol or procedural requirements, or for administrative reasons. HPV 9-valent vaccine: 1st dose 1 day prior to first QL1706 administration; 2nd dose 2 months after 1st dose; 3rd dose 6 months after 1st dose.

Conditions

• Cervical Cancer Stage IVB

Interventions

Type	Name	Description
DRUG	Trial drug: QL1706, HPV 9-valent vaccine	QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on day 1 of each cycle and once every 3 weeks (21 days).

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-03-18
• Last updated: 2025-03-28