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Monoclonal Antibodies
Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
Tampa, FL
Phase 1
Waitlist Available
Led By Peter Forsyth, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and tolerability of combining vorinostat and pembrolizumab with chemotherapy and radiotherapy to treat glioblastoma.
See full description
Eligible Conditions
- Glioblastoma
- Brain Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Overall Survival (OS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment4 Interventions
Pembrolizumab and Vorinostat Combined with Temozolomide and Radiotherapy. There are two parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). Dose Expansion: Twenty participants will be treated with vorinostat at the maximum tolerated dose (MTD) from dose escalation phase, pembrolizumab, temozolomide and radiation. During the maintenance phase, participants will receive Temozolomide (for the first 6 months), vorinostat (for 12 months), and pembrolizumab (for 12 months).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880
Vorinostat
2014
Completed Phase 3
~1600
Pembrolizumab
2017
Completed Phase 3
~2630
Radiotherapy
2017
Completed Phase 3
~2610
Find a Location
Closest Location:H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
575 Previous Clinical Trials
145,004 Total Patients Enrolled
3 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
Merck Sharp & Dohme LLCIndustry Sponsor
4,086 Previous Clinical Trials
5,223,896 Total Patients Enrolled
31 Trials studying Glioblastoma
3,739 Patients Enrolled for Glioblastoma
Peter Forsyth, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
6 Total Patients Enrolled
Solmaz Sahebjam, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
4 Previous Clinical Trials
97 Total Patients Enrolled
1 Trials studying Glioblastoma
17 Patients Enrolled for Glioblastoma