Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548752
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2020-09-12
Brief Title:
Testing the Addition of Pembrolizumab an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Clinical Trial of Olaparib Pembrolizumab vs Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients With Germline BRCA1 or BRCA2 Mutations
Status:
RECRUITING
Status Verified Date:
2024-07
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 II trial studies whether adding pembrolizumab to olaparib standard of care works better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or BRCA2 mutations that has spread to other places in the body metastatic BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins These proteins help repair damaged deoxyribonucleic acid DNA and therefore play a role in ensuring the stability of each cells genetic material When either of these genes is mutated or altered such that its protein product is not made or does not function correctly DNA damage may not be repaired properly As a result cells are more likely to develop additional genetic alterations that can lead to some types of cancer including pancreatic cancer Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Olaparib is an inhibitor of PARP a protein that helps repair damaged DNA Blocking PARP may help keep tumor cells from repairing their damaged DNA causing them to die PARP inhibitors are a type of targeted therapy The addition of pembrolizumab to the usual treatment of olaparib may help to shrink tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the progression free survival PFS of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib pembrolizumab compared to olaparib alone as maintenance therapy
SECONDARY OBJECTIVES
I To evaluate the safety and tolerability associated with the combination of olaparib pembrolizumab versus vs olaparib alone as maintenance therapy
II To evaluate the overall survival OS of patients treated with olaparib pembrolizumab compared to olaparib alone as maintenance therapy
III To evaluate the overall response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST 11 including confirmed and unconfirmed complete and partial response of patients treated with olaparib pembrolizumab compared to olaparib alone in the subset of patients with measurable disease
IV To evaluate the duration of response DoR by RECIST 11 in patients treated with olaparib pembrolizumab compared to olaparib alone
BANKING OBJECTIVE
I To bank tissue and blood specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive olaparib orally PO twice daily BID on days 1-21 and pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Beginning in cycle 19 patients receive olaparib PO BID on days 1-42 and pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive olaparib PO BID on days 1-21 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo computed tomography CT scan or magnetic resonance imaging MRI tumor biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed for 30 days and every 6 months for 3 years from the date of randomization
I To evaluate the progression free survival PFS of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib pembrolizumab compared to olaparib alone as maintenance therapy
SECONDARY OBJECTIVES
I To evaluate the safety and tolerability associated with the combination of olaparib pembrolizumab versus vs olaparib alone as maintenance therapy
II To evaluate the overall survival OS of patients treated with olaparib pembrolizumab compared to olaparib alone as maintenance therapy
III To evaluate the overall response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST 11 including confirmed and unconfirmed complete and partial response of patients treated with olaparib pembrolizumab compared to olaparib alone in the subset of patients with measurable disease
IV To evaluate the duration of response DoR by RECIST 11 in patients treated with olaparib pembrolizumab compared to olaparib alone
BANKING OBJECTIVE
I To bank tissue and blood specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive olaparib orally PO twice daily BID on days 1-21 and pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Beginning in cycle 19 patients receive olaparib PO BID on days 1-42 and pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive olaparib PO BID on days 1-21 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo computed tomography CT scan or magnetic resonance imaging MRI tumor biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed for 30 days and every 6 months for 3 years from the date of randomization
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-2020-06838 | REGISTRY | None | None |
| S2001 | OTHER | None | None |
| S2001 | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |