drugset / Trial / NCT04395079

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

NCT04395079 ↗

Phase 2 Active not recruiting 9 enrolled Jonsson Comprehensive Cancer Center AstraZeneca · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-08-07
Primary completion
2024-10-11
Completion
2026-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody — Intravenous
Subject Tremelimumab Monoclonal antibody — Intravenous