PD-1 and PD-L1 Inhibitors with Chemotherapy for Metastatic, Persistent, and Recurrent Cervical Cancer
This study aims to evaluate the effectiveness of PD-1 and PD-L1 Inhibitors used in combination with chemotherapy on the overall survival of individuals with metastatic, persistent, or recurrent cervical cancer.
PD-1 antibody
+ PD-L1 antibody
+ Chemotherapy and bevacizumab (CT-BEV)
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Treatment Study
Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on treating metastatic, persistent, and recurrent cervical cancer using a method called chemoimmunotargeted therapy. The study aims to validate, develop, and implement this approach for medical care. It involves patients with cervical cancer that has spread to other parts of the body, continued to grow despite treatment, or returned after a period of remission. The importance of this study lies in exploring new treatment options to potentially improve care and outcomes for individuals with these challenging forms of cervical cancer. The treatment in this trial involves the use of PD-1 and PD-L1 immune checkpoint inhibitors in combination with chemotherapy, with or without a drug called bevacizumab. These immune checkpoint inhibitors work by helping the immune system recognize and attack cancer cells. Participants will receive this treatment, and the results will be evaluated. The primary outcomes measured are median overall survival, which is the time point at which half of the patients are still alive after starting treatment, and overall survival, which is the time from randomization to death from any cause. These measurements will help determine the effectiveness of the treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age ≥18-≤75 years. * Histologically confirmed diagnosis. * One of the forms of the cervical cancer: 1. Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018); 2. Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018); 3. Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018). * Availability of material for determining PD-L-1 expression for immunotherapy candidates. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No contraindications to chemotherapy, immunotherapy, or bevacizumab. * Signed informed consent to participate in the study. Exclusion Criteria: * Presence of another active malignant invasive neoplasm. * Pregnancy or lactation period.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
N.N. Alexandrov National Caner Centre
Minsk, BelarusOpen N.N. Alexandrov National Caner Centre in Google Maps