Pembrolizumab for Glioblastoma (GBM)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma (GBM)+1 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of drugs as a possible treatment for recurrent glioblastoma (GBM), a brain tumor.

Eligible Conditions
  • Glioblastoma (GBM)
  • Glioblastoma

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 24 months

24 months
Grade 3 or Higher Treatment-Related Toxicity Rate
Median Overall Survival (OS)
Objective Response Rate (ORR)
Month 6
6-month Progression-Free Survival (PFS6)
Day 14
Gene expression profiling (GEP) score
Tumor infiltrating lymphocytes (TIL) Density

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

3 Treatment Groups

Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomide
1 of 3
Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapy
1 of 3
Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomide
1 of 3

Experimental Treatment

78 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomideExperimental Group · 3 Interventions: Temozolomide, Pembrolizumab, Olaparib · Intervention Types: Drug, Drug, Drug
Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapy
Drug
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomideExperimental Group · 3 Interventions: Temozolomide, Pembrolizumab, Olaparib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1940
Pembrolizumab
2017
Completed Phase 3
~2240
Olaparib
2017
Completed Phase 4
~2090

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

L. Nicolas Gonzalez Castro, MD, PhDLead Sponsor
Patrick Y. Wen, MDLead Sponsor
9 Previous Clinical Trials
700 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,684 Previous Clinical Trials
4,958,050 Total Patients Enrolled
Luis N Gonzalez Castro, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Patrick Y Wen, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
494 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to adhere to the dosing and visit schedules and agree to record medication times accurately and consistently in a daily diary.
You must be at least 18 years old to sign this consent form.
You are of childbearing potential and are not pregnant or breastfeeding.
You have a KPS ≥ 70 and ECOG Performance Status ≤ 1.
Participants must be able to swallow oral medications

Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
Massachusetts General Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%