Your session is about to expire
← Back to Search
Pembro + Olaparib with TMZ for Recurrent Glioblastoma
Study Summary
This trial is studying a combination of drugs as a possible treatment for recurrent glioblastoma (GBM), a brain tumor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I had major surgery less than 4 weeks ago or am still dealing with its side effects.I have enough tissue from a previous surgery for glioblastoma available for study.It has been enough time since my last cancer treatment to start a new one.I have a history of lung inflammation not caused by an infection.I have had viral therapy or vaccines for my brain tumor.I do not have any ongoing serious illnesses that could interfere with the study.I am among the first 10 in Arm A and have both types of tumor tissue for removal.My disease can be surgically removed after it has progressed.I have not received any colony-stimulating factors in the last 28 days.You need to have an MRI scan done no more than two weeks before enrolling in the study.I can swallow pills.I am not pregnant and will use birth control during treatment.I do not have GI issues that could affect medication absorption.I have previously received immunotherapy targeting specific immune checkpoints.You are currently taking part in another study that involves testing new medications or treatments.I am not taking medication that strongly affects enzyme CYP3A.My cancer has spread to the lining of my brain or other parts of my body.You need to be able to read and agree to sign a paper that explains the study details.It has been over 4 weeks since my last surgery or 1 week since my biopsy.My brain tumor is a Grade IV glioblastoma without IDH mutation.I can follow the treatment schedule and keep a daily record of my medication times.I am currently taking blood thinners like warfarin.I agree to follow the contraception guidelines and not donate sperm for 180 days after my last treatment dose.I haven't taken high doses of steroids like dexamethasone (>2 mg/day) for 3 days in a row within the last 2 weeks.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding.I don't need to stop my tumor treating fields therapy for this trial.I am at least 18 years old.I am allergic to medications similar to olaparib, temozolomide, or pembrolizumab.I am not pregnant or breastfeeding and either cannot become pregnant or will follow the study's birth control advice.I have a heart condition that is currently causing symptoms.My tumor is mainly in my brainstem or spinal cord.I have been diagnosed with an immunodeficiency or HIV.My tumor is large enough for surgery and study purposes.You have a mental health condition or substance abuse problem that could make it difficult for you to follow the trial's requirements.I am mostly independent and can carry out daily activities.I have had significant bleeding in or around my tumor.It's been 12 weeks since my last radiation therapy, or I have confirmed tumor growth.I have recovered from major side effects of my previous treatments.I have an active infection needing treatment or a known viral infection like HIV or hepatitis.I am mostly independent and can carry out daily activities.My tumor has a 1p/19q co-deletion.I have an autoimmune disease treated with medication in the last 2 years.I have or might have a blood disorder related to MDS or AML.I have an active tuberculosis infection.I have been treated with drugs targeting blood vessel growth in cancer.I have previously been treated with a PARP inhibitor.My brain tumor is a Grade IV glioblastoma without IDH mutation.My brain cancer has returned for the first or second time.My latest MRI shows my tumor has grown.I do not have another cancer that is getting worse or needs treatment.I am currently taking medication for epilepsy.My cancer has an IDH mutation.I haven't taken immune-weakening drugs (except steroids) in the last 6 months.I have moderate to severe diarrhea.I have a history of heart problems.I haven't had serious bleeding or blood clotting issues in the past year.My GBM has returned once or twice after treatment.I can swallow pills.I am currently using herbal medications.My MRI shows my tumor has grown according to specific criteria.
- Group 1: Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomide
- Group 2: Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapy
- Group 3: Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Pembrolizumab received FDA approval for clinical use?
"Pembrolizumab's efficacy has not been proven, but there is some data supporting its safety, giving it a score of 2."
How many people can participate in this research project?
"The trial is currently looking for 78 patients from 3 locations, as stated on clinicaltrials.gov. This information was last updated on 10/21/2022, which is also when the posting for this study went up."
Are we still able to sign up for this research project?
"The most recent update on clinicaltrials.gov suggests that this trial is still recruiting patients. The first posting was on October 21st, 2022 and there have been no changes since then."
What goals does this experiment hope to realize?
"The primary outcome of this six-month clinical trial is Progression-Free Survival (PFS6), which will be measured through surgery 14 days after treatment begins. Other outcomes include the Gene expression profiling (GEP) score, Median Overall Survival (OS), and Grade 3 or Higher Treatment-Related Toxicity Rate."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Share this study with friends
Copy Link
Messenger