RecruitingPhase 1Phase 2NCT06543576

External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

35 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radiation therapy (external beam plus brachytherapy), chemotherapy, and immunotherapy for people with stage IVB cervical cancer — meaning the cancer has spread to distant parts of the body. **You may be eligible if...** - You are at least 18 years old with confirmed stage IVB cervical cancer (adenocarcinoma, adenosquamous, or squamous cell) - You have not yet received chemotherapy or radiation therapy for this cancer - You have measurable tumors that can be tracked on scans - Any side effects from prior cancer treatments have mostly resolved **You may NOT be eligible if...** - You have already received systemic chemotherapy or radiation for cervical cancer - You have active autoimmune disease or are on immune-suppressing medications - You have severe or uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

RADIATIONBrachytherapy

Undergo brachytherapy

DRUGCisplatin

Given IV

RADIATIONExternal Beam Radiation Therapy

Undergo EBRT

DRUGPaclitaxel

Given IV

BIOLOGICALPembrolizumab

Given IV

OTHERQuestionnaire Administration

Ancillary study


Locations(4)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

University of California San Diego (UCSD)

San Diego, California, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06543576


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