DOMEC - phase II trial of Durvalumab (MEDI4736) and Olaparib in Metastatic/recurrentEndometrial Cancer, a DGOG trial. - DOMEC

eiden University Medical Center0 sites55 target enrollmentJuly 8, 2019

DrugsOlaparib IMFINZI

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: eiden University Medical Center
Enrollment: 55
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 8, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

eiden University Medical Center

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 or cytologically 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.
•6\. Measurable lesions outside irradiated field or progressive measurable lesions in irradiated area
•7\. Not eligible for hormonal therapy (because of negative hormone receptor/poor differentiation, or after failure of hormonal therapy).
•8\. Previous failure of chemotherapy, or refusal to undergo chemotherapy or chemo\-naive patients not suitable for chemotherapy.
•9\. WHO performance 0\-1

Exclusion Criteria

•1\. another investigational product during the last month.
•2\. Any previous treatment with PARP inhibitor and/or any previous treatment with a PD1 or PD\-L1 inhibitor.
•3\. History of another primary malignancy that could conceivably be active evaluated by the study physician.
•4\. History of leptomeningeal carcinomatosis. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids (maximum 2 mg/day) before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
•5\. Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
•6\. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.
•7\. Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
•8\. Any unresolved toxicity NCI CTCAE Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
•? Patients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
•? Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and olaparib may be included only after consultation with the Study Physician.