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PARP Inhibitor
Triple Therapy for Brain Cancer
Phase 2
Recruiting
Led By Lauren Schaff, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed IDH-wildtype glioma that has recurred following therapy (consisting of at least maximum feasible surgical resection and radiation therapy).
Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test if a combo of pembrolizumab, olaparib, & temozolomide is safe & effective for people with a glioma that didn't respond to previous treatment or came back after treatment.
Who is the study for?
Adults with a glioma brain tumor that's come back or didn't respond to treatment can join. They must be in good physical condition, able to take oral meds, and have no major organ issues. Pregnant women can't participate, and those who can have children must use birth control.Check my eligibility
What is being tested?
The trial is testing how safe and effective the combination of pembrolizumab, olaparib, and temozolomide is for treating recurrent gliomas. Participants will receive all three drugs to see if they work better together.See study design
What are the potential side effects?
Possible side effects include immune system reactions, blood cell changes leading to increased infection risk or bleeding problems, fatigue, nausea or vomiting from chemotherapy drugs like temozolomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My glioma has returned after surgery and radiation.
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My liver function tests are within the required limits.
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It's been weeks since my last cancer drug treatment.
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I have a harmful mutation in one of the genes linked to DNA repair.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I am fully active or able to carry out light work.
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I can swallow and keep down pills.
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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 (Cohort A)
Side 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
2Treatment groups
Experimental Treatment
Group I: Recurrent enhancing grade II and III IDH-mutated gliomas that have failed previous therapyExperimental Treatment2 Interventions
All patients will receive pembrolizumab for two cycles prior to the addition of olaparib and temozolomide. Combination olaparib and temozolomide will be added in cycle 3. Combination therapy will continue through cycle 11 (cycles 3-11 = 27 weeks or approximately 6 months). Patients will then continue on pembrolizumab maintenance for a maximum of 35 cycles (two years) or until progression of disease or unacceptable toxicity.
Group II: Recurrent IDH-wildtype gliomas and homologous recombination deficiency (HRD).Experimental Treatment2 Interventions
Five patients will receive pembrolizumab for two cycles prior to the addition of olaparib and temozolomide. Combination olaparib and temozolomide will be added in cycle 3. Combination therapy will continue through cycle 11 (cycles 3-11 = 27 weeks or approximately 6 months). Patients will then continue on pembrolizumab maintenance for a maximum of 35 cycles (two years) or until progression of disease or unacceptable toxicity. This cohort will be analyzed descriptively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,824 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,878 Total Patients Enrolled
Lauren Schaff, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My glioma has returned after surgery and radiation.You are expected to live for at least 12 more weeks.I haven't needed treatment for an autoimmune disease in the last 2 years.I do not have a history of lung inflammation not caused by infection.I have mostly recovered from side effects of my previous cancer treatment.I do not have any active cancer except for certain skin cancers or in situ cervical cancer that has been treated.I am not taking any strong medication that affects liver enzymes.I am not on high-dose steroids or any drugs that weaken my immune system.I do not have an infection that needs treatment with drugs.It has been over 12 weeks since my last radiation treatment.I agree to follow the contraception guidelines and not donate sperm for 120 days after my last treatment dose.My liver function tests are within the required limits.My blood clotting tests are normal or within the safe range if I'm on blood thinners.I don't have any serious health issues that would stop me from joining this study.It's been weeks since my last cancer drug treatment.I do not have any active fungal or known viral infections like HIV or hepatitis.I am not pregnant, not breastfeeding, and meet one of the specific conditions.My cancer's genetic makeup, including IDH status, will be or has been tested.I've been on a stable dose of corticosteroids, not exceeding 2mg/day, for over 4 weeks.I have never had active tuberculosis.I haven't had a live vaccine in the last 30 days.I have a harmful mutation in one of the genes linked to DNA repair.I am not taking any strong medications that affect liver enzymes.My kidney function, measured by creatinine or GFR, is within the required range.I am fully active or able to carry out light work.I have had multiple treatments for my condition.I am not currently receiving any other cancer treatment.I can swallow and keep down pills.I am able to have children and have not tested positive for pregnancy recently.I am 18 years old or older.My glioma has returned after initial treatment and does not have a specific genetic deletion.My organs are functioning well and I've been on a stable dose of corticosteroids for at least 5 days.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent IDH-wildtype gliomas and homologous recombination deficiency (HRD).
- Group 2: Recurrent enhancing grade II and III IDH-mutated gliomas that have failed previous therapy
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.
What is the unique element of this clinical test?
"Pembrolizumab has been researched since 2002, when the first study was conducted by Schering-Plough. The drug progressed to Phase 2 after the initial 60 person trial in 2002. Nowadays, there are live trials for Pembrolizumab being conducted all over the world--1365 studies in 3162 cities and 66 countries to be exact."
Answered by AI
What are some of the short and long-term risks associated with Pembrolizumab?
"Pembrolizumab has been evaluated in a Phase 2 trial, so there is some data supporting its safety. However, since this stage of testing does not look at efficacy, it received a score of 2 from our team."
Answered by AI
Are people with the disease still being recruited for this experiment?
"That is accurate, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. The posting date was 1/14/2022 with the most recent edit on 4/13/2022. The study requires 57 more participants that will be drawn from 7 different medical sites around the country."
Answered by AI
How many test subjects are there in total for this experiment?
"That is correct, according to the most recent information on clinicaltrials.gov, this trial posted on 1/14/2022 and edited on 4/13/2022 is actively seeking 57 participants at 7 locations."
Answered by AI
In how many different locations is this trial being run today?
"Patients are currently being enrolled at 7 study sites, which are situated in Commack, Harrison, New york and 4 other locations. If you choose to participate in this trial, it is best to select the location that is closest to you to avoid extensive travel."
Answered by AI
What are some of the conditions that Pembrolizumab has been approved to help alleviate?
"Pembrolizumab is a medication that oncologists often prescribe to cancer patients. It can also be used to help those with unresectable melanoma, microsatellite instability high, or a high risk of recurrence."
Answered by AI
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