← Back to Search

Platinum-containing compounds

Treatment (EBRT, brachytherapy, chemotherapy, immunotherapy) for Cervical Adenocarcinoma

Phase 1 & 2
Waitlist Available
Led By Dana M Chase
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

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.

Who is the study for?
This trial is for patients with advanced stage IVB cervical cancer. Participants should be eligible to receive radiation, chemotherapy with cisplatin and paclitaxel, and immunotherapy drugs like bevacizumab and pembrolizumab. Specific eligibility criteria are not provided but typically include factors such as age, overall health status, and previous treatments.
What is being tested?
The study tests the combination of external beam radiation therapy (EBRT) & brachytherapy with chemotherapy (cisplatin & paclitaxel) plus immunotherapy drugs (bevacizumab & pembrolizumab). It aims to assess if this treatment can safely improve outcomes in stage IVB cervical cancer patients.
What are the potential side effects?
Possible side effects may include fatigue from radiation; kidney issues or hearing loss from cisplatin; nerve damage or allergic reactions from paclitaxel; high blood pressure or bleeding from bevacizumab; immune-related reactions like inflammation of organs from pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Progression free survival (PFS)
Secondary study objectives
Duration of response
Overall survival
PFS

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (EBRT, brachytherapy, chemotherapy, immunotherapy)Experimental Treatment8 Interventions
PART 1: Patients receive cisplatin 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 CT, PET/CT, and/or MRI throughout the study. Patients also undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Brachytherapy
2007
Completed Phase 3
~2100
Cisplatin
2013
Completed Phase 3
~1940
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Pembrolizumab
2017
Completed Phase 2
~2010
Biospecimen Collection
2004
Completed Phase 2
~1720
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,551 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,936 Previous Clinical Trials
5,169,567 Total Patients Enrolled
Dana M ChasePrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
~23 spots leftby Jan 2030