External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
NCT Number: NCT06543576
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Cervical Adenocarcinoma|Cervical Adenosquamous Carcinoma|Cervical Squamous Cell Carcinoma|Stage IVB Cervical Cancer American Joint Committee on Cancer (AJCC) v8
Interventions: BIOLOGICAL: Bevacizumab|PROCEDURE: Biospecimen Collection|RADIATION: Brachytherapy|DRUG: Cisplatin|RADIATION: External Beam Radiation Therapy|DRUG: Paclitaxel|BIOLOGICAL: Pembrolizumab|OTHER: Questionnaire Administration
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-31
Completion Date: 2031-01-31
Locations: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|University of California San Diego (UCSD), San Diego, California, 96960, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|University of Virginia Cancer Center, Charlottesville, Virginia, 22908, United States

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.

Primary Outcome Measures: Progression free survival (PFS), Will be described using Kaplan-Meier plots and median estimates., From the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years|Incidence of adverse events, Up to 30 days after completion of study treatments
Secondary Outcome Measures: PFS, Will be described using Kaplan-Meier plots and median estimates., From the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years|Overall survival, Will be described using Kaplan-Meier plots and median estimates., Up to 3 years|Duration of response, Up to 3 years