Actively Recruiting
External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-08-15
35
Participants Needed
4
Research Sites
339 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of informed consent
- Histologically confirmed diagnosis of stage IVB cervical adenocarcinoma, adenosquamous carcinoma, or squamous cell carcinoma
- No prior systemic chemotherapy or radiation therapy for cervical cancer
- Adverse events from previous anticancer therapies recovered to grade 1 or baseline, or grade 2 neuropathy if endocrine related and treated
- Provides written informed consent
- Measurable disease based on RECIST 1.1 criteria
- Archival or new tumor biopsy tissue available, preferably formalin-fixed, paraffin embedded blocks
- PD-L1 status with a combined positive score (CPS) over 1 using FDA-approved testing
- ECOG performance status of 0 to 1 evaluated within 7 days before starting treatment
- Hepatitis B positive patients must have received antiviral therapy for at least 4 weeks and have undetectable viral load before randomization
- Hepatitis C patients must have undetectable viral load and completed curative antiviral therapy at least 4 weeks before randomization
- Well-controlled HIV infection on stable antiretroviral therapy with CD4 count ≥ 350 cells/mm³ and virologic suppression for at least 12 weeks
- Specific blood counts and liver and kidney function tests within defined normal limits prior to treatment start
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Previous hysterectomy (lymphadenectomy allowed)
- Prior systemic anticancer therapy or investigational agents within 4 weeks
- Prior radiotherapy for cervical cancer
- Live vaccine within 30 days before first treatment dose
- Use of investigational agents or devices within 4 weeks before study treatment
- Immunodeficiency or chronic immunosuppressive therapy exceeding prednisone 10 mg daily within 7 days before treatment
- Active malignancy requiring treatment within past 3 years, except some skin cancers and low-risk prostate cancer
- Active carcinomatous meningitis; untreated or progressing brain metastases
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapies
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- History of hepatitis B or active hepatitis C infection unless meeting study criteria
- Incomplete recovery from major surgery or ongoing complications
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last treatment
- History of allogenic tissue or solid organ transplant
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California San Diego (UCSD)
San Diego, California, United States, 96960
Not Yet Recruiting
3
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
4
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Not Yet Recruiting
Research Team
J
Jenny Lester
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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