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PARP Inhibitor
Pembro + Olaparib with TMZ for Recurrent Glioblastoma
Phase 2
Recruiting
Led By Luis N Gonzalez Castro, MD
Research Sponsored by Patrick Wen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be able to swallow oral medications.
Participants must have histologically World Health Organization Grade IV IDH wildtype glioblastoma by IDHR132H immunohistochemistry or variants including gliosarcoma or IDH wildtype diffuse glioma with molecularly features of glioblastoma (EGFR amplification, TERT promoter mutation, or concurrent gain of Chromosome 7 and loss of Chromosome 10) (Brat et al., 2018). IDH mutational status can be established via immunohistochemistry and/or next-generation sequencing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a possible treatment for recurrent glioblastoma (GBM), a brain tumor.
Who is the study for?
This trial is for adults with recurrent glioblastoma, a type of brain tumor. They must be in good physical condition (KPS ≥ 70), not pregnant or breastfeeding, able to swallow pills, and have adequate organ function. Patients should be at their first or second relapse and haven't had certain prior treatments like anti-PD-1 or PARP inhibitors.Check my eligibility
What is being tested?
The study tests a combination therapy using Pembrolizumab, Olaparib, and Temozolomide as potential treatments for recurrent glioblastoma. It aims to see if this mix can stop the tumor from growing after previous treatment has failed.See study design
What are the potential side effects?
Possible side effects include immune system reactions that might affect organs, fatigue, nausea, blood-related issues such as anemia or clotting problems. Each patient may experience these differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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My brain tumor is a Grade IV glioblastoma without IDH mutation.
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I am at least 18 years old.
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I am not pregnant or breastfeeding.
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I am mostly independent and can carry out daily activities.
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I am mostly independent and can carry out daily activities.
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My brain tumor is a Grade IV glioblastoma without IDH mutation.
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My brain cancer has returned for the first or second time.
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My latest MRI shows my tumor has grown.
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I do not have another cancer that is getting worse or needs treatment.
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I can swallow pills.
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My MRI shows my tumor has grown according to specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month Progression-Free Survival (PFS6)
Tumor infiltrating lymphocytes (TIL) Density
Secondary outcome measures
Gene expression profiling (GEP) score
Grade 3 or Higher Treatment-Related Toxicity Rate
Median Overall Survival (OS)
+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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
3Treatment groups
Experimental Treatment
Group I: Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapyExperimental Treatment1 Intervention
Cohort 2 participants will be randomized into either group a or b (1:1):
Group B participants will receive pembrolizumab monotherapy before and after surgery.
Pembrolizumab Before Surgery: Day 1 of the pre-surgical treatment cycle.
Pembrolizumab After Surgery: Day 1 of every other 21-day cycle (once every 6 weeks).
Group II: Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomideExperimental Treatment3 Interventions
Cohort 2 participants will be randomized into either group a or b (1:1):
Group A participants will receive pembrolizumab, olaparib, and temozolomide before and after surgery.
Olaparib 2x daily on Days 1-7 of each 21-day study cycle.
Temozolomide 1x daily on Days 1-7 of each 21-day study cycle.
Pembrolizumab on Day 1 of every other 21-day cycle (once every 6 weeks).
Group III: Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomideExperimental Treatment3 Interventions
Following a 3 + 3 dose escalation design 6-18 participants will receive:
Olaparib 2x daily on Days 1-7 of each 21-day study cycle.
Temozolomide 1x daily on Days 1-7 of each 21-day study cycle.
Pembrolizumab on Day 1 of every other 21-day cycle (once every 6 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
Patrick Wen, MDLead Sponsor
2 Previous Clinical Trials
313 Total Patients Enrolled
2 Trials studying Glioblastoma
313 Patients Enrolled for Glioblastoma
L. Nicolas Gonzalez Castro, MD, PhDLead Sponsor
Patrick Y. Wen, MDLead Sponsor
9 Previous Clinical Trials
703 Total Patients Enrolled
7 Trials studying Glioblastoma
618 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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