Study on Brachytherapy with Durvalumab or Tremelimumab for Treating Gynecological Cancers Resistant to Platinum Therapy

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT04395079

This clinical trial is exploring whether combining internal radiation therapy (brachytherapy) with the immunotherapy drugs durvalumab or tremelimumab can effectively treat gynecological cancers that are resistant to platinum-based treatments, have returned, or have spread.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to see if using brachytherapy, a type of internal radiation therapy, along with the immunotherapy drugs durvalumab or tremelimumab, can help treat gynecological cancers that are resistant to platinum-based treatments, have come back, or have spread to other parts of the body. Brachytherapy involves placing radioactive material directly into or near the tumor to kill cancer cells. Immunotherapy with durvalumab or tremelimumab may help the immune system attack cancer cells and prevent them from growing and spreading. This study aims to find out if this combination works better for treating these types of cancers.

Description

The study has two main goals: to determine the safety of combining brachytherapy with tremelimumab and to find out how long patients can live without their cancer getting worse when treated with brachytherapy and either durvalumab or tremelimumab.

Secondary goals include evaluating how well the treatment controls the tumor, the overall response rate, and how long the response lasts. The study will also look at the safety and tolerability of the treatment combinations.

Patients will be randomly assigned to one of two groups:

Group 1: Patients receive durvalumab through an IV on the first day of each 28-day cycle, for up to 13 cycles, unless the cancer progresses or side effects become unacceptable. Brachytherapy is given on the eighth day of each cycle, repeating every 21 days for three sessions.
Group 2: Patients receive tremelimumab through an IV on the first day of each 28-day cycle, for 2-4 cycles, unless the cancer progresses or side effects become unacceptable. Brachytherapy is given on the eighth day of each cycle, repeating every 21 days for three sessions.

After completing the study treatment, patients will have follow-up visits every 12 weeks.

Eligibility Criteria

Inclusion Criteria

Have gynecological cancer (such as ovarian, endometrial, or cervical cancer) that is resistant to platinum-based treatments, has returned, or has spread.
Have at least one tumor that can be measured by scans and has not been treated with radiation before.
Cancer must be treatable with brachytherapy.
Be able to give informed consent and follow study requirements.
Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have a life expectancy of at least 12 weeks.
Agree to provide a tumor sample for analysis.
Meet specific blood test requirements for hemoglobin, neutrophil count, platelet count, liver function, and kidney function.
Women must be post-menopausal or have a negative pregnancy test and agree to use contraception if of childbearing potential.

Exclusion Criteria

Have used checkpoint inhibitors before.
Have had radiation that overlaps with the planned brachytherapy site.
Have had extensive radiation treatment recently.
Have a performance status of 2 or greater.
Be involved in the study's planning or conduct.
Be participating in another clinical study with a therapeutic agent.
Have unresolved side effects from previous cancer treatments.
Have certain autoimmune or inflammatory disorders.
Have uncontrolled illnesses or infections.
Have a history of another primary cancer unless treated and inactive for 5 years.
Have untreated brain metastases or spinal cord compression.
Have a history of active primary immunodeficiency.
Be pregnant or breastfeeding, or not willing to use birth control.
Have allergies to study drugs or their components.
Be deemed unsuitable by the investigator.

Locations

FACILITY	ZIP	CITY	STATE
UCLA / Jonsson Comprehensive Cancer Center	90095	Los Angeles	California

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