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NCT04395079
Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies
Phase 2 trial testing Durvalumab in Metastatic Malignant Female Reproductive System Neoplasm in 9 participants. Participants enrolled and being followed up; not accepting new ones.
11 October 2024
Quick facts
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 7 August 2020 |
| Primary completion | 11 October 2024 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Durvalumab — full drug profile →
- Internal Radiation Therapy
- Tremelimumab (TREMELIMUMAB) — full drug profile →
Conditions studied
- Metastatic Malignant Female Reproductive System Neoplasm — all drugs for Metastatic Malignant Female Reproductive System Neoplasm →
- Platinum-Resistant Malignant Female Reproductive System Neoplasm — all drugs for Platinum-Resistant Malignant Female Reproductive System Neoplasm →
- Recurrent Malignant Female Reproductive System Neoplasm — all drugs for Recurrent Malignant Female Reproductive System Neoplasm →
- Refractory Malignant Female Reproductive System Neoplasm — all drugs for Refractory Malignant Female Reproductive System Neoplasm →
Sponsor
Jonsson Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Metastatic Malignant Female Reproductive System Neoplasm or Platinum-Resistant Malignant Female Reproductive System Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04395079
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
Other recruiting trials for Metastatic Malignant Female Reproductive System Neoplasm
Currently open trials in the same condition.
- NCT05092373 — Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel i · Phase 1 · recruiting
- NCT04819997 — A Nurse-Led Intervention for Fear of Progression in Advanced Cancer · NA · active not recruiting
- NCT04516135 — Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With M · Phase 2 · active not recruiting
Other Jonsson Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
- NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04395079 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04395079.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing