NL-OMON49312
Recruiting
Phase 2
DOMEC - phase II trial of Durvalumab (MEDI4736) and Olaparib in Metastatic/recurrent Endometrial Cancer, a DGOG trial - - DOMEC
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Endometrial cancer inclusive carcinosarcoma of the endometrium
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 55
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Must provide written informed consent prior to performance of study\-specific
- •procedures or
- •assessments, and must be willing to comply with treatment and follow\-up
- •assessments.
- •2\. Age \> 18 years old
- •3\. Histologically confirmed diagnosis of endometrial cancer or carcinosarcoma
- •of the endometrium. Besides central revision, a tumor block or 20 slides are
- •asked for TR.
- •4\. Metastatic disease or locally advanced tumor not amenable to local therapy.
- •5\. Documented progressive disease before enrolment.
Exclusion Criteria
- •1\. Participation in another clinical study with an investigational product
- •during the last month or
- •previous enrolment in the present study.
- •2\. Any previous treatment with PARP inhibitor, including olaparib and/or any
- •previous treatment with a PD1 or PD\-L1 inhibitor, including durvalumab.
- •3\. History of another primary malignancy that could conceivably be active
- •evaluated by the study physician. except for Examples include, but are not
- •limited to:
- •\* Malignancy treated with curative intent and with no known active disease \>\=5
- •years before the first dose of IP and of low potential risk for recurrence.
Outcomes
Primary Outcomes
Not specified
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