A Phase II trial of durvalumab (Medi 4736) in advanced endometrial cancerA multi-centre Phase II trial to determine the activity and safety of durvalumab in advanced endometrial cancer

niversity of Sydney0 sites71 target enrollmentJanuary 19, 2017

ConditionsAdvanced endometrial cancer Cancer - Womb (Uterine or endometrial cancer)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Advanced endometrial cancer
Sponsor: niversity of Sydney
Enrollment: 71
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 19, 2017

End Date

December 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

niversity of Sydney

Eligibility Criteria

Inclusion Criteria

•Patients with advanced endometrial carcinoma suitable for chemotherapy
•Adults, aged 18 years and older, with histologically or cytologically confirmed adenocarcinoma of endometrial origin
•Advanced or recurrent disease that is not amenable to local therapy with curative intent such as surgical resection and/or radiotherapy
•Assessment result for DNA mismatch repair (MMR) protein expression in tumour tissue by immunohistochemistry (IHC) must be available. This must include assessment for 4 MMR proteins: MLH1, MSH2, MSH6 and PMS2
•Tumour tissue (FFPE) available for PD\-L1 testing at a central laboratory
•Agreement to undergo a repeat core biopsy of tumour tissue if the only available tumour tissue sample was obtained before previous chemotherapy or more than 1 year previously, and the investigator judges that the lesion can be biopsied without undue risk.
•At least 1 target lesion according to RECIST v1\.1
•ECOG performance status of 0\-2
•Adequate bone marrow, renal and liver function
•Willing and able to start treatment within 7 days of registration and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments

Exclusion Criteria

•Suspected brain or leptomeningeal metastases, untreated brain metastases or current clinical or radiological progression of known brain metastases, or requirement for steroid therapy for brain metastases. Patients with treated brain metastases are eligible if they have been stable and off steroids for 3 weeks or longer.
•Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks before registration, or persisting adverse events (\>Grade 1\) due to a previously administered agent.
•Any condition requiring systemic treatment with either corticosteroids (\>10mg daily prednisone or equivalent dose of alternative corticosteroid) or other immunosuppressive medications within 28 days of durvalumab administration. Intranasal, inhaled or topical steroids are permitted in the absence of active autoimmune disease.
•History of any known or suspected autoimmune disease other than vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, or psoriasis not requiring systemic treatment within the last 2 years.
•Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency.
•Prior treatment with durvalumab, or with any other anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CTLA\-4 antibody or any other antibody or drug specifically targeting T cell co\-stimulation or immune checkpoint pathways.
•Life expectancy of less than 12 weeks.
•Systemic infection requiring IV antibiotics within 14 days before the first dose of durvalumab.
•Receipt of live attenuated vaccination within 30 days prior to enrolment.
•Known history of interstitial lung disease from any cause