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NCT04395079 · ClinicalTrials.gov registry record · Phase 2
Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies
A Phase 2 study of Recurrent Malignant Female Reproductive System Neoplasm and Metastatic Malignant Female Reproductive System Neoplasm, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04395079: Active Phase 2 study of Recurrent Malignant Female Reproductive System Neoplasm and Metastatic Malignant Female Reproductive System Neoplasm, sponsored by Jonsson Comprehensive Cancer Center.
NCT04395079 is a Phase 2 study of Recurrent Malignant Female Reproductive System Neoplasm and Metastatic Malignant Female Reproductive System Neoplasm that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 9 participants, below the 1,041-participant average among 3 other Recurrent Malignant Female Reproductive System Neoplasm trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04395079, a Phase 2 study of Recurrent Malignant Female Reproductive System Neoplasm and Metastatic Malignant Female Reproductive System Neoplasm, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Toxicity will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 criteria.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL Tremelimumab
- RADIATION Internal Radiation Therapy
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT04395079 still lists
NCT04395079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,041-participant average among 3 other Recurrent Malignant Female Reproductive System Neoplasm trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Recurrent Malignant Female Reproductive System Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT04395079 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04395079 about?
NCT04395079 is a clinical study titled "Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies". 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 sprea...
What is the current status of trial NCT04395079?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2020-08-07. Estimated completion is 2026-12-01.
What conditions does trial NCT04395079 study?
This clinical trial studies the following conditions: Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Malignant Female Reproductive System Neoplasm, Platinum-Resistant Malignant Female Reproductive System Neoplasm, Refractory Malignant Female Reproductive System Neoplasm.
What interventions are being tested in trial NCT04395079?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL), Internal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04395079?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04395079 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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