Ignite Creation Date:
2024-05-06 @ 9:18 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02953457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2016-11-01
Brief Title:
Olaparib Durvalumab and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Evaluation of Olaparib in Combination With Durvalumab Medi4736 and Tremelimumab in the Treatment of Recurrent Platinum Sensitive or Resistant or Refractory Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer in Patients Who Carry a BRCA1 or BRCA2 Mutation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies the side effects and best dose of olaparib when give together with durvalumab and tremelimumab and to see how well they work in treating patients with ovarian fallopian tube or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation that has come back or has not responded to treatment Drugs such as olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors cells with BRCA1 or BRCA2 mutation Monoclonal antibodies such as durvalumab and tremelimumab may help stimulate the immune system in different ways to attack and stop tumor cells from growing Giving olaparib with durvalumab and tremelimumab may work better in treating patients with ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and toxicity of the combination of PARP inhibitor olaparib with anti-PD-L1 antibody durvalumab and anti-CTLA4 antibody tremelimumab Phase I II To assess the impact of the combination of olaparib with durvalumab and tremelimumab on progression free survival PFS rates Phase II
SECONDARY OBJECTIVES
I To assess the impact of the combination of olaparib with durvalumab and tremelimumab on anti-tumor immune responses in patients with recurrent platinum sensitive or resistant or refractory epithelial ovarian fallopian tube or primary peritoneal cancer who carry a germline andor somatic BRCA1 or BRCA2 mutation andor a homologous recombination deficiency HRD
II To assess the impact of the combination of olaparib with durvalumab and tremelimumab on PFS and overall survival OS in patients with recurrent platinum sensitive or resistant or refractory epithelial ovarian fallopian tube or primary peritoneal cancer who carry a germline andor somatic BRCA1 or BRCA2 mutation andor a HRD
OUTLINE This is a phase I dose-escalation study of olaparib followed by a phase II study
Patients receive olaparib orally PO twice daily BID and tremelimumab intravenously IV over 1 hour and durvalumab IV over 1 hour on day 1 Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 days and every 2 months thereafter
I To assess the safety and toxicity of the combination of PARP inhibitor olaparib with anti-PD-L1 antibody durvalumab and anti-CTLA4 antibody tremelimumab Phase I II To assess the impact of the combination of olaparib with durvalumab and tremelimumab on progression free survival PFS rates Phase II
SECONDARY OBJECTIVES
I To assess the impact of the combination of olaparib with durvalumab and tremelimumab on anti-tumor immune responses in patients with recurrent platinum sensitive or resistant or refractory epithelial ovarian fallopian tube or primary peritoneal cancer who carry a germline andor somatic BRCA1 or BRCA2 mutation andor a homologous recombination deficiency HRD
II To assess the impact of the combination of olaparib with durvalumab and tremelimumab on PFS and overall survival OS in patients with recurrent platinum sensitive or resistant or refractory epithelial ovarian fallopian tube or primary peritoneal cancer who carry a germline andor somatic BRCA1 or BRCA2 mutation andor a HRD
OUTLINE This is a phase I dose-escalation study of olaparib followed by a phase II study
Patients receive olaparib orally PO twice daily BID and tremelimumab intravenously IV over 1 hour and durvalumab IV over 1 hour on day 1 Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 days and every 2 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-01598 | REGISTRY | None | None |
| I 288216 | OTHER | Roswell Park Cancer Institute | None |