Your session is about to expire
← Back to Search
PARP Inhibitor
Pembrolizumab + Olaparib for Breast Cancer
Phase 2
Recruiting
Led By Monica Mita, MD
Research Sponsored by Monica Mita
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have ECOG 0 or 1
Have documented BRCA deleterious germline or somatic mutation and/or HDR-defect
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will evaluate the use of immunotherapy and PARP inhibition to treat advanced breast cancer associated with a germline BRCA mutation or HDR-defect.
Who is the study for?
This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) combined with olaparib (a PARP inhibitor) in patients with incurable advanced breast cancer due to BRCA mutations or HDR defects. The main goal is to see how well this combination works by measuring the overall response rate according to specific criteria.See study design
What are the potential side effects?
Possible side effects may include immune-related reactions affecting organs, infusion-related symptoms during administration of pembrolizumab, nausea from olaparib intake along with potential blood cell count changes leading to anemia or infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have a confirmed BRCA mutation or HDR defect.
Select...
My breast cancer has a BRCA mutation or HDR defect and is getting worse despite treatment.
Select...
I have a tumor that can be measured and hasn't been treated with radiation.
Select...
I am postmenopausal or cannot have children and agree to use two effective birth control methods.
Select...
I have a preserved tumor sample available for testing.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) per RECIST1.1
Secondary outcome measures
Clinical Benefit Rate (CBR = CR+PR+SD) per RECIST 1.1
Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) per RECIST 1.1
Overall survival (OS)
+1 moreOther outcome measures
Exploratory: CBR based on immune-related (ir)RECIST
Exploratory: DOR based on immune-related (ir)RECIST
Exploratory: ORR based on immune-related (ir)RECIST
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions
This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Monica MitaLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
2 Trials studying Breast Cancer
82 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,037 Total Patients Enrolled
58 Trials studying Breast Cancer
7,514 Patients Enrolled for Breast Cancer
Monica Mita, MDPrincipal Investigator - Cedars-Sinal Medical Center
Cedars-Sinai Medical Center, Sound Physicians Platinum Group Pc
University De Medical Si Farm (Medical School)
University Tx Medical Sch-San Antonio (Residency)
9 Previous Clinical Trials
479 Total Patients Enrolled
4 Trials studying Breast Cancer
112 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I am not on steroids or immunosuppressants as of three days ago.I have a history of HIV or active Hepatitis B/C.I have an autoimmune disease treated with medication in the last 2 years.I have received an organ or tissue transplant from another person.I don't have any health issues that could affect the trial's results.You are expected to live for at least 16 more weeks.I have a confirmed BRCA mutation or HDR defect.I will use a condom during and for 3 months after treatment when with a partner who can get pregnant.I have cancer that has spread to my brain or spinal cord.I have a lung condition not caused by an infection.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I am postmenopausal or cannot have children and agree to use two effective birth control methods.I have another cancer that is getting worse or needs treatment.I have a tumor that can be measured and hasn't been treated with radiation.I cannot take pills by mouth and have stomach issues affecting medication absorption.I will not need any cancer treatment other than the trial.I have not received a live vaccine in the last 30 days.My breast cancer has a BRCA mutation or HDR defect and is getting worse despite treatment.I have not had chemotherapy, targeted therapy, or radiation in the last 3 weeks.I have a preserved tumor sample available for testing.You are allergic to pembrolizumab or any of the ingredients in it.I am 18 years old or older.I have lasting side effects from cancer treatment, but not hair loss.I have active tuberculosis.Your heart test shows a problem that can be fixed.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial an unprecedented experiment?
"Since the first trial in 2005, sponsored by AstraZeneca and involving 98 participants, pembrolizumab has been on a path of intensive research. Over the years it was granted Phase 1 drug approval and now there are 1114 active clinical trials being conducted across 66 countries spanning 3058 cities around the world."
Answered by AI
How many participants are currently involved in this research project?
"Affirmative. The information found on clinicaltrials.gov states that this research project is actively searching for participants, with the original posting occurring on September 10th 2017 and a recent update made to it on May 20th 2022. This study requires the recruitment of twenty individuals from one medical site."
Answered by AI
What medical ailments does Pembrolizumab address most frequently?
"Pembrolizumab is a viable option for patients diagnosed with unresectable melanoma, high microsatellite instability, and increased risk of recurrence."
Answered by AI
To what extent could Pembrolizumab be detrimental to a patient's wellbeing?
"Data from the Phase 2 trial suggests Pembrolizumab is relatively safe, resulting in a rating of two on our scale. However, there are currently no clinical results available to support its effectiveness."
Answered by AI
Are there any other research initiatives that have explored the potential of Pembrolizumab?
"Currently, 1114 research studies are underway examining pembrolizumab. Of these ongoing trials, 143 have entered Phase 3 of the clinical trial process. Moreover, while Houston is home to a majority of the investigations into this drug's efficacy, 42747 centers in total across the globe are involved in its evaluation."
Answered by AI
Are there remaining vacancies in this clinical trial?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial is presently recruiting patients; originally posted on September 10th 2017 and most recently amended on May 20th 2022 - with a search for 20 individuals from 1 site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger