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Monoclonal Antibodies

Temozolomide for Glioblastoma

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

Study Summary

This trial is testing the safety and tolerability of combining vorinostat and pembrolizumab with chemotherapy and radiotherapy to treat glioblastoma.

Eligible Conditions
  • Glioblastoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Overall Survival (OS)

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
~1930
Vorinostat
2014
Completed Phase 3
~1600
Pembrolizumab
2017
Completed Phase 2
~2010
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,471 Total Patients Enrolled
3 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,532 Total Patients Enrolled
30 Trials studying Glioblastoma
3,030 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
2018. "Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03426891.
~3 spots leftby Apr 2025
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