Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients… (NCT05033756) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
Germany11 participantsStarted 2022-07-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant must provide written informed consent.
. Male/Female participants must be ≥18 years of age at the day of signing informed consent and must be willing to comply with the study specific procedures.
. Histologically confirmed metastatic or advanced, unresectable HER2 negative (0, 1+ by IHC or ISH amplified \< 2.0) breast cancer which is not eligible for curative treatment.
. Cohort 1: Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious (known or predicted to be detrimental/lead to loss of function) irrespective of HRD status.
. Cohort 2: Germline mutation in ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2 that is predicted to be deleterious (known or predicted to be detrimental/lead to loss of function) irrespective of HRD status.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of the combination of pembrolizumab and olaparib via overall response rate
. Cohort 3: High HRD status and no germline mutation in one of the above mentioned genes of cohort 1 or cohort 2.
. Cohort 3: Availability of FFPE tumor material for further validation of HRD status (bridging tests).
. Cohorts 2 and 3: Patients must have been treated with first line chemotherapy, if this chemotherapy is standard of care in this therapy situation.
Exclusion criteria
. Has histologically confirmed HER2 positive (3+ by IHC or ISH amplified ≥ 2.0) breast cancer.
. Cohorts 1 and 2: germline mutations in BRCA1, BRCA2, ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2 that are considered to be non-detrimental (e.g., "variants of uncertain/unknown clinical significance" or "benign polymorphism" etc.).
. Cohort 3: no high tumor HRD.
. Rapidly progressive disease which requires combination chemotherapy.
. Current participation in another investigational trial within 4 weeks prior to the first dose of trial treatment
. Known hypersensitivity to pembrolizumab or olaparib or any of its excipients.
. Prior systemic anti-cancer therapy within 4 weeks prior to allocation or no recovery from all AEs due to previous therapies to ≤ grade 1, excluding alopecia and ≤ grade 2 peripheral neuropathy.
. Prior treatment with a checkpoint inhibitor or a PARP inhibitor.