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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorNorthern Jiangsu People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients with unsystematically treated cervical cancer, who voluntarily participate in the clinical study; fully understand and informed about the study and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all the trial procedures.

With histologically confirmed diagnosis of cervical cancer, a pathology report and pathology slides are required.

have at least one measurable lesion as assessed by the investigator according to RECIST 1.1.

Recovery of AE associated with prior antitumor therapy to CTCAE ≤ Grade 1 (except for Grade 2 alopecia).

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Trial drug: QL1706, HPV 9-valent vaccine

Treatment groups

35 Participants
are divided into 1 treatment group

Locations

This trial has no locations