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Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

NCT04395079 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-09

No results posted yet for this study

Summary

This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.

Conditions

  • Metastatic Malignant Female Reproductive System Neoplasm
  • Platinum-Resistant Malignant Female Reproductive System Neoplasm
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Refractory Malignant Female Reproductive System Neoplasm

Interventions

BIOLOGICAL

Durvalumab

Given IV

RADIATION

Internal Radiation Therapy

Undergo brachytherapy

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Albert J Chang · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2024-10-11
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395079 on ClinicalTrials.gov