Loading clinical trials...

Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer

NCT03951415•Leiden University Medical Center

Summary

The DOMEC trial is designed as a Dutch Gynecological Oncology Group (DGOG), prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer or carcinosarcoma of the uterus to investigate the efficacy of the combination therapy of olaparib tablets and durvalumab IV.

Detailed Description

The prognosis of recurrent or persistent endometrial carcinoma not amenable to local therapy is poor. First line therapy exists of platinum-based chemotherapy or hormonal therapy. No standard subsequent-line therapy has been described.The combination of Poly(ADP-ribose) polymerases (PARP) inhibition and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of recurrent endometrial cancer. The DOMEC trial is designed to investigate this treatment combination among all molecular subgroups. The DOMEC trial is designed as a DGOG, prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. Patients must have had one prior platinum-based chemotherapeutic regimen or not be able/willing to get chemotherapy. The aim is to investigate the efficacy of the combination therapy of olaparib tablets 300mg twice daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival. Secondary objectives are to investigate objective response rate, overall survival, safety and predictive biomarkers.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Written informed consent
•Age \> 18 years old
•Histologically confirmed diagnosis of endometrial cancer or carcinosarcoma of the endometrium.
•Metastatic disease or locally advanced tumor not amenable to local therapy.
•Documented progressive disease before enrolment.
•Measurable lesions outside irradiated field or progressive measurable lesions in irradiated area
•Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (except intranasal and inhaled corticosteroids or systemic prednisone ≤ 10 mg/day)
•Major surgery ≤2 weeks of starting study treatment
•History of active primary immunodeficiency
•Active or prior documented autoimmune or inflammatory disorders, with exception of: vitiligo or alopecia, hypothyroidism stable on hormone replacement, any chronic skin condition that does not require systemic therapy, celiac disease controlled by diet alone
+6 more criteria

Exclusion Criteria

•Previous failure of chemotherapy, or refusal to undergo chemotherapy or chemo-naive patients not suitable for chemotherapy.
•WHO performance 0-1
•Adequate organ system function as measured within 28 days prior to administration of study treatment, as defined below:
•* Haemoglobin ≥ 10.0 g/dL, with no blood transfusion in the past 28 days.
•* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
•* Platelet count ≥ 100 x 109/L
•* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (not applicable to Gilbert's syndrome)
•* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN
•* Patients must have creatinine clearance estimated of ≥51 mL/min estimated using the Cockcroft-Gault equation or 24 hr urine clearance.
•Life expectancy of at least 16 weeks.
+9 more criteria

Locations (8)

Amsterdam UMC, AMC

Amsterdam, Netherlands

NKI-AVL

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

RadboudMC

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Key Dates

Start Date

July 8, 2019

Primary Completion Date

August 1, 2021

Completion Date

August 1, 2021

Last Updated

April 1, 2021

Enrollment

ACTUAL participants

Conditions

Endometrial NeoplasmsUterine NeoplasmsEndometrium Cancer

Interventions

PARP inhibitor and Anti-PD-L1

DRUG

A Study of LY4175408 in Participants With Advanced Cancer

NCT07046923

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma+3 more

View study

RECRUITING

Registry Platform Ovarian and Endometrial Cancer

NCT05129969

Ovarian CancerEndometrial Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer

Inclusion Criteria

Exclusion Criteria

A Study of LY4175408 in Participants With Advanced Cancer

Registry Platform Ovarian and Endometrial Cancer

Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

The Role of POLE Mutation in High Risk Endometrial Cancer.

Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue