Trials / Unknown
UnknownNCT03951415
Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Leiden University Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PARP inhibitor and Anti-PD-L1 | olaparib tablets 300mg twice daily orally and durvalumab 1500mg by IV infusion every 4 weeks |
Timeline
- Start date
- 2019-07-08
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2019-05-15
- Last updated
- 2021-04-01
Locations
8 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03951415. Inclusion in this directory is not an endorsement.