Endometrial Neoplasms Clinical Trial
Official title:
Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02865889 -
Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications
|
N/A | |
| Completed |
NCT00377520 -
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
|
Phase 2 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05682950 -
Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05974995 -
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
|
N/A | |
| Recruiting |
NCT03291106 -
Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
|
||
| Recruiting |
NCT03291275 -
Survival Outcomes of Uterine Malignancies in Chinese Population
|
N/A | |
| Completed |
NCT00341458 -
Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
|
||
| Terminated |
NCT05067972 -
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05795244 -
Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)
|
Phase 2 | |
| Recruiting |
NCT05770102 -
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04865289 -
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
|
Phase 3 | |
| Completed |
NCT03270995 -
Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study
|
N/A | |
| Terminated |
NCT01969396 -
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
|
N/A | |
| Completed |
NCT01460979 -
Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT05869123 -
Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT02900248 -
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
|
||
| Active, not recruiting |
NCT05588076 -
Endometrial Lesions Predictions
|
||
| Active, not recruiting |
NCT03935282 -
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
|
N/A |