← Back to Search

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 below
Select...
I can swallow pills.
Select...
My brain tumor is a Grade IV glioblastoma without IDH mutation.
Select...
I am at least 18 years old.
Select...
I am not pregnant or breastfeeding.
Select...
I am mostly independent and can carry out daily activities.
Select...
I am mostly independent and can carry out daily activities.
Select...
My brain tumor is a Grade IV glioblastoma without IDH mutation.
Select...
My brain cancer has returned for the first or second time.
Select...
My latest MRI shows my tumor has grown.
Select...
I do not have another cancer that is getting worse or needs treatment.
Select...
I can swallow pills.
Select...
My MRI shows my tumor has grown according to specific criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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

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
~2140

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

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05463848 — Phase 2
Glioblastoma Research Study Groups: Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomide, Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapy, Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomide
Glioblastoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05463848 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463848 — Phase 2

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
~22 spots leftby Dec 2024