External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for Stage IVB Cervical Cancer
This study is testing a new combination of treatments for stage IVB cervical cancer. It combines external beam radiation therapy (EBRT), which uses a machine to aim high-energy rays at the cancer from outside the body, and brachytherapy, which places radioactive material directly into or near the tumor. These radiation treatments are given along with chemotherapy drugs, cisplatin and paclitaxel, and immunotherapy drugs, bevacizumab and pembrolizumab. Researchers want to see if this combination is safe and effective. You may be able to join if you are at least 18 years old and have stage IVB cervical cancer that has not been treated with chemotherapy or radiation before. The study will look at how long people live without their cancer growing or returning, and also track any side effects. The current status of this study is unclear, and it plans to enroll about 35 people.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll about 35 participants.
- What's involved
- You would undergo blood sample collection and receive bevacizumab, brachytherapy, cisplatin, and external beam radiation therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track how long you live without your cancer growing or returning for up to 3 years. They will also track adverse events for up to 30 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06543576
External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~35 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:BevacizumabBiospecimen CollectionBrachytherapyCisplatinExternal Beam Radiation TherapyPaclitaxel
At a glance
Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over 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
+1 more outcome measured
Conditions
Where it's being run
4 sites across 3 statesCalifornia2
Oklahoma1
Virginia1
Study leadership
- Dana M Chase, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage IVB cervical cancer will be enrolled in this study
Patients with stage IVB adenocarcinoma, adenosquamous carcinoma, or squamous-cell carcinoma of the cervix that has not yet been treated with systemic chemotherapy or radiation therapy
Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible
The participant provides written informed consent for the trial
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
Patients must have PD-L1 status, CPS score of over 1. PD-L1 status will be determined per institutional standards via the Food and Drug Administration (FDA)-approved test, Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx kit with combined positive score (CPS) interpretation
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
Known history of HBV infection
As mandated by local health authority
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Known history of HCV infection
As mandated by local health authority
HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:
Participants on ART must have a CD4+ T-cell count ≥ 350 cells/mm\^3 at the time of screening
Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study
The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)
Absolute neutrophil count (ANC) ≥ 1500/µL (collected within 10 days prior to the start of study)
Platelets ≥ 100 000/µL (collected within 10 days prior to the start of study)
Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (collected within 10 days prior to the start of study). Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
Creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) ≥ 30 mL/min for participant with creatinine levels \> 1.5 × institutional ULN (collected within 10 days prior to the start of study)
Creatinine clearance (CrCl) should be calculated per institutional standard
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN (collected within 10 days prior to the start of study)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) (collected within 10 days prior to the start of study)
International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (collected within 10 days prior to the start of study)
Exclusion
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
Has received prior hysterectomy. (Prior lymphadenectomy permitted)
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to /allocation
Has received prior radiotherapy for cervical cancer
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, and prostate specific antigen (PSA) \< 10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded
Has known active carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients
Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \[qualitative\]) infection.
Has not adequately recovered from major surgery or has ongoing surgical complications
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
Has had an allogenic tissue/solid organ transplant
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
What this trial measures
- Progression free survival (PFS)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
Will be described using Kaplan-Meier plots and median estimates.
- Incidence of adverse eventsUp to 30 days after completion of study treatments