Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05033756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-04-03
Brief Title:
Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency COMPRENDO
Sponsor:
Institut fuer Frauengesundheit
Organization:
Institut fuer Frauengesundheit
Study Overview
Official Title:
A Phase II Open-Label Study for the Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation in BRCA12 ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 or a Homologous Recombination Deficiency
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
COMPRENDO
Brief Summary:
This study will examine the combination of pembrolizumab and olaparib in three populations
Cohort 1 aBC patients with a germline mutation in BRCA1 or BRCA2
cohort 2 aBC patients with a germline mutation in one of the moderate penetrance homologous repair genes ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 and
cohort 3 aBC patients with a HRD as assessed by whole genome sequencing
Cohort 1 aBC patients with a germline mutation in BRCA1 or BRCA2
cohort 2 aBC patients with a germline mutation in one of the moderate penetrance homologous repair genes ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 and
cohort 3 aBC patients with a HRD as assessed by whole genome sequencing
Detailed Description:
This is a multicenter prospective phase II one-arm three-cohort open-label study of pembrolizumab in combination with olaparib in patients with advanced HER2 negative breast cancer who have either
a deleterious germline mutation in BRCA12 irrespective of tumor HRD status Cohort 1
or a deleterious germline mutation in ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 irrespective of tumor HRD status Cohort 2
or a centrally confirmed high tumor HRD status but no deleterious germline mutation in BRCA12 ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 Cohort 3 HRD assessment needs to be performed on a tumor biopsy not more than 12 months before study entry
All eligible participants according to the definition of cohorts 1-3 will receive pembrolizumab iv 200 mg q3w in combination with olaparib tablets 300 mg twice daily total dose 600 mg per day
Study medication will be withdrawnended in case of onset of unacceptable toxicities progression withdrawal of consent death or end of study whichever occurs first Safety follow-up is planned for 90 days after the last application of study medication Participants will be followed for survival for a maximum of 18 months after therapy start
a deleterious germline mutation in BRCA12 irrespective of tumor HRD status Cohort 1
or a deleterious germline mutation in ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 irrespective of tumor HRD status Cohort 2
or a centrally confirmed high tumor HRD status but no deleterious germline mutation in BRCA12 ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 Cohort 3 HRD assessment needs to be performed on a tumor biopsy not more than 12 months before study entry
All eligible participants according to the definition of cohorts 1-3 will receive pembrolizumab iv 200 mg q3w in combination with olaparib tablets 300 mg twice daily total dose 600 mg per day
Study medication will be withdrawnended in case of onset of unacceptable toxicities progression withdrawal of consent death or end of study whichever occurs first Safety follow-up is planned for 90 days after the last application of study medication Participants will be followed for survival for a maximum of 18 months after therapy start
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AGO-B-051 | OTHER | None | None |
| 2020-001940-25 | EUDRACT_NUMBER | AGO Study Group | None |