Brachytherapy + Immunotherapy for Recurrent Gynecological Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any concurrent cancer treatments, and there is a required washout period (time without taking certain medications) of at least 21 days for previous anticancer therapies before starting the study drug.
What data supports the effectiveness of the drug combination of durvalumab and tremelimumab for treating recurrent gynecological cancer?
The combination of durvalumab and tremelimumab has shown effectiveness in improving survival in other cancers, such as non-small cell lung cancer and hepatocellular carcinoma, when used with chemotherapy. This suggests potential benefits for recurrent gynecological cancer, although direct evidence for this specific condition is not yet available.12345
Is the combination of durvalumab and tremelimumab generally safe for humans?
The combination of durvalumab and tremelimumab has been studied in various cancers, showing that serious side effects can occur, such as reduced appetite and diarrhea. In one study, 63.6% of patients experienced severe side effects, mostly related to chemotherapy, but the combination's safety profile was considered expected.15678
How is the treatment of brachytherapy combined with durvalumab and tremelimumab unique for recurrent gynecological cancer?
This treatment is unique because it combines brachytherapy (a type of internal radiation therapy) with two immunotherapy drugs, durvalumab and tremelimumab, which work by enhancing the body's immune response to fight cancer cells. This combination aims to improve outcomes by using both radiation and immune system activation, which is different from traditional chemotherapy or radiation alone.123910
What is the purpose of this trial?
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.
Research Team
Albert Chang, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
This trial is for women with certain gynecological cancers (like ovarian, endometrial, or cervical) that haven't responded to platinum therapy and may have spread. Participants should be in good enough health to undergo internal radiation, not pregnant, able to consent, and without serious infections like TB or hepatitis. They shouldn't have used checkpoint inhibitors before or had recent major surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive durvalumab or tremelimumab intravenously, followed by brachytherapy. Durvalumab is administered every 28 days for up to 13 cycles, and tremelimumab for 2-4 cycles. Brachytherapy is administered every 21 days for 3 fractions.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Internal Radiation Therapy
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology