Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer (NCT03277482) | Clinical Trial Compass
TerminatedPhase 1
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
Stopped: Expansion cohort was not open
United States16 participantsStarted 2018-06-01
Plain-language summary
This research study is evaluating the safety and effectiveness of 2 immunotherapy drugs in combination with radiation therapy as a possible treatment for recurrent or metastatic gynecologic cancer.
The names of the immunotherapy drugs involved in this study are:
* Durvalumab
* Tremelimumab
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Participants must have histologically or cytologically confirmed endometrial, ovarian (including ovarian epithelial, fallopian tube, primary peritoneal), cervical, vaginal, or vulvar cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Participants must have measurable disease, defined as at least 1 lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥20 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. See also 3.1.10 as all measurable/target lesions must not be located within the planned radiation field for the expansion cohort.
* Patients must have progressive disease following prior therapy. Specifically, patients must have progressed on platinum-based chemotherapy.
* At least 21 days must have elapsed from prior therapy (chemotherapy or radiation).
* Age of 18 years or older. Because no dosing or adverse event data are currently available on the use of durvalumab in combination with tremelimuma…
What they're measuring
1
Maximum Tolerated Dose (MTD) of Radiotherapy with durvalumab and tremelimumab