Study on Radiation, Chemotherapy, and Immunotherapy for Treating Advanced Cervical Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT06543576

This clinical trial is exploring a combination of radiation therapy, chemotherapy, and immunotherapy to treat patients with advanced stage IVB cervical cancer. The study aims to determine if this approach is safe and effective in controlling the cancer.

Patient Parameters

Parameter	Options

Program Overview

This study is testing a treatment plan for patients with advanced cervical cancer (stage IVB) that includes external beam radiation therapy (EBRT), brachytherapy, chemotherapy with cisplatin and paclitaxel, and immunotherapy with bevacizumab and pembrolizumab. EBRT uses a machine to direct high-energy rays at the cancer from outside the body, while brachytherapy places radioactive material directly into or near the tumor. Chemotherapy drugs like cisplatin and paclitaxel work by stopping cancer cells from growing and dividing. Bevacizumab helps slow tumor growth by preventing the formation of blood vessels that supply the tumor, and pembrolizumab is a type of protein that helps the immune system attack cancer cells. The study aims to see if this combination can safely and effectively treat stage IVB cervical cancer.

Description

The main goal of this study is to see if adding radiation therapy to chemotherapy and immunotherapy can safely improve outcomes for patients with newly diagnosed stage IVB cervical cancer. Researchers are also looking at whether this combination can improve the overall response rate, survival, and quality of life for patients.

The study is divided into two parts:

Part 1: Patients receive chemotherapy drugs (cisplatin and paclitaxel) and immunotherapy drugs (pembrolizumab and bevacizumab) through an IV on the first day of each cycle. These cycles repeat every 21 days for a total of 6 cycles, unless the cancer progresses or side effects become too severe. After completing these cycles, patients have a 3-week break.

Part 2: Patients undergo external beam radiation therapy (EBRT) for 25 treatments over 5 weeks and brachytherapy for 3-5 treatments. They continue to receive pembrolizumab and bevacizumab every 21 days for up to 2 years, unless the cancer progresses or side effects become too severe. If the cancer progresses after 2 years, patients may receive an additional year of pembrolizumab.

Throughout the study, patients will have regular imaging tests (CT, PET/CT, MRI) and blood tests to monitor their response to treatment. After completing the study treatment, patients will have follow-up visits at 30 days, every 6 weeks for up to 1 year, and then every 9 weeks.

Eligibility Criteria

Inclusion Criteria

Be at least 18 years old with a confirmed diagnosis of stage IVB cervical cancer.
Have not received prior systemic chemotherapy or radiation therapy for cervical cancer.
Have measurable disease based on specific medical criteria.
Provide a tumor tissue sample for analysis.
Have a PD-L1 status with a combined positive score (CPS) over 1.
Have a good overall health status (ECOG performance status of 0 to 1).
If positive for hepatitis B, must be on antiviral therapy with an undetectable viral load.
If previously infected with hepatitis C, must have an undetectable viral load after treatment.
If HIV-positive, must have well-controlled HIV with a stable antiretroviral treatment regimen.
Meet specific blood count and organ function criteria.

Exclusion Criteria

Have received prior therapy with certain immune checkpoint inhibitors.
Have had a hysterectomy (removal of the uterus).
Have received prior systemic anti-cancer therapy or radiation for cervical cancer.
Have received a live vaccine within 30 days before starting the study.
Have a diagnosis of immunodeficiency or are on high-dose steroid therapy.
Have another active cancer that required treatment in the past 3 years.
Have active brain metastases or carcinomatous meningitis.
Have severe allergies to pembrolizumab or its components.
Have active autoimmune disease requiring treatment in the past 2 years.
Have a history of lung disease requiring steroids.
Have an active infection requiring treatment.
Have not recovered from major surgery or have ongoing complications.
Have psychiatric or substance abuse disorders affecting study participation.
Are pregnant, breastfeeding, or planning to conceive during the study.
Have had an organ transplant.
Have a history of certain HIV-related conditions.

Locations

FACILITY	ZIP	CITY	STATE
UCLA / Jonsson Comprehensive Cancer Center	90095	Los Angeles	California
University of California San Diego (UCSD)	96960	San Diego	California
University of Oklahoma Health Sciences Center	73104	Oklahoma City	Oklahoma
University of Virginia Cancer Center	22908	Charlottesville	Virginia

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