Recurrent Malignant Female Reproductive System Neoplasm Clinical Trial
Official title:
Brachytherapy With Durvalumab (MEDI4736) and Tremelimumab in Subjects With Platinum-Resistant or Refractory and 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 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 OBJECTIVES: I. To determine the safety of the treatment combination consisting of brachytherapy and tremelimumab. (Safety lead-in) II. To determine the median progression-free survival with brachytherapy and checkpoint inhibition with either durvalumab or tremelimumab. (Dose expansion) SECONDARY OBJECTIVES: I. To estimate the efficacy of brachytherapy and durvalumab or brachytherapy and tremelimumab in terms of: Ia. Local control of the irradiated tumor. Ib. Overall response rate. Ic. Response at non-irradiated lesions in subjects with multiple sites of disease subjects. Id. Duration of response. Ie. Disease specific survival. If. Overall survival. II. To further determine the safety and tolerability of brachytherapy with durvalumab and brachytherapy with tremelimumab (expansion cohorts). EXPLORATORY OBJECTIVE: I. To explore the immunologic changes associated with the combination of brachytherapy with durvalumab and brachytherapy with tremelimumab. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive durvalumab intravenously (IV) on day 1. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive tremelimumab IV on day 1. Treatment repeats every 28 days for 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks. ;
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