Trials / Recruiting

RecruitingNCT06543576

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

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 35 (estimated)

Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To demonstrate that radiotherapy can be safely integrated into chemotherapy and pembrolizumab with bevacizumab in newly diagnosed stage IVB cervical cancer to improve outcomes. SECONDARY OBJECTIVE: I. To demonstrate improvements with overall response rate, overall survival (OS), and duration of response with the addition of radiation therapy to standard of care in stage IVB cervical cancer. EXPLORATORY OBJECTIVES: I. To demonstrate improved quality of life and disease-related toxicity with the addition of radiation therapy to standard of care chemotherapy in stage IVB cervical cancer. II. To explore the association of known risk factors (age, race/ethnicity, smoking status, baseline quality of life, combined positive score \[CPS\] score 1-10 versus \> 10, and performance status with the change in QOL, treatment outcomes, and toxicities. III. To explore circulating tumor deoxyribonucleic acid (ctDNA) as a biomarker to monitor the response to upfront chemotherapy-immunotherapy and subsequent radiation. IV. To use T cell receptor repertoire sequencing (TCRseq) to define T cell clones present in the tumor and to establish their concordance with peripheral blood T cell clones at baseline and in response to therapy. OUTLINE: PART 1: Patients receive cisplatin intravenously (IV), paclitaxel IV, pembrolizumab IV over 30 minutes, and bevacizumab IV on day 1 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive no treatment for 3 weeks. PART 2: Patients undergo EBRT for 25 treatments delivered over 5 weeks, and brachytherapy over 3-5 treatments. Patients also receive pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle. Cycles for immunotherapy repeat every 21 days for a total of 2 years in the absence of disease progression or unacceptable toxicity. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. Patients undergo computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI) throughout the study. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients follow up at 30 days and every 6 weeks for up to 1 year then every 9 weeks.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
RADIATION	Brachytherapy	Undergo brachytherapy
DRUG	Cisplatin	Given IV
RADIATION	External Beam Radiation Therapy	Undergo EBRT
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
OTHER	Questionnaire Administration	Ancillary study

Timeline

Start date: 2025-07-29
Primary completion: 2031-01-31
Completion: 2032-01-31
First posted: 2024-08-09
Last updated: 2025-08-15

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study
FDA-regulated device study

Source: ClinicalTrials.gov record NCT06543576. Inclusion in this directory is not an endorsement.