To explore the efficacy and safety of administrating QL1706 in patients with recurrent and/or metastatic cervical cancer who had developed resistance to prior PD-1/PD-L1 antibody therapies.
The application of PD-1/PD-L1 antibodies in cervical cancer is becoming increasingly widespread. However, monotherapy with PD-1 inhibitors demonstrates only a 10-20% response rate and a median progression-free survival of merely 2 months in patients with recurrent or metastatic cervical cancer. To address the issue of resistance to PD-1/PD-L1 antibodies in cervical cancer patients, we plan to conduct a clinical study. This study will administer a PD-1/CTLA-4 bispecific antibody to patients with recurrent or metastatic cervical cancer who are resistant to PD-1/PD-L1 therapy, thereby evaluating the efficacy and safety profile of the bispecific antibody in this specific patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Enrolled patients will receive intravenous infusion of QL1706 once every 3 weeks at a dose of 5.0 mg/kg until disease progression, death, intolerable treatment toxicity, or withdrawal from the clinical trial for any reason.
ORR
The objective response rate (ORR) assessed by the Independent Review Committee (IRC) (according to RECIST v1.1).
Time frame: 1-year
DOR
The duration of response (DOR) assessed according to RECIST v1.1.
Time frame: 1-year
DCR
The disease control rate (DCR) assessed according to RECIST v1.1
Time frame: 1-year
OS
Time from diagnosis of disease to death due to any cause
Time frame: 1-year
PFS
Time from diagnosis of disease to disease progression or death due to any cause
Time frame: 1-year
Profile of adverse events
Frequency and severity of treatment-related toxicities, whether immune-related or non-immune-related
Time frame: 3 years
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