Active — Not RecruitingPhase 2

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

United States9 participantsStarted 2020-08-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with platinum-resistant or refractory, recurrent or metastatic gynecological malignancies, including ovarian, endometrial, or cervical cancer are eligible for enrollment. Subjects unsuitable or refusing platinum-based chemotherapy are allowed to enrolled * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria. Thus, subjects with metastatic disease must have at least 1 lesion, not previously irradiated, that can be accurately measured at baseline as \>=10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurement as per RECIST v1.1 guidelines * Disease amenable to be treated safely with brachytherapy * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of \>= 12 weeks * Subjects must consent to provide an archived tumor specimen from within 12 months prior to study entry (ie, from subject signing consent to participate in the study). If not available, subjects should have at least 1 lesion amenable to biopsy and consent to provide a pre-treatment fresh biopsy. Additional archival tissue from beyond 12 months prior to study entry is also req…

What they're measuring

Incidence of adverse events (safety lead-in)

Timeframe: Up to 90 days

Progression free survival (PFS) (dose expansion)

Timeframe: From the first day of the treatment to the first occurrence of disease progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 or death, assessed up to 2 years

Trial details

NCT IDNCT04395079

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-11

View on ClinicalTrials.gov More Metastatic Malignant Female Reproductive System Neoplasm trials