A Phase 1 interventional study of Pembrolizumab and Vorinostat in Glioblastoma, Brain Tumor and GBM, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1, Interventional, and Treatment
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Among 11 studies testing vorinostat in Glioblastoma — none open to participants now, 1 under way, none of them phase 3. Vorinostat · Glioblastoma.
Among the 11 studies testing vorinostat in Glioblastoma, this one is the 8th largest by enrollment, is the only one that started in 2018, is one of 4 in phase 1, and was the 11th registered.
2,135 studies on the registry are indexed under Glioblastoma; 467 are open to participants now.
Browse Glioblastoma studies →None of the 11 studies testing vorinostat in Glioblastoma is open now. The open studies under Glioblastoma, anywhere →
Vorinostat: first FDA approval 2006 (ZOLINZA). What it is approved for, and how studies give it, is on its page →
Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 6
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 36 across 1,756 interventional studies indexed under Glioblastoma.
Median enrollment 44 across the 11 interventional studies. Of the 10 that completed or were terminated, 8 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 4 most frequent:
H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
H. Lee Moffitt Cancer Center and Research Institute has 4 studies filed under Glioblastoma — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing vorinostat in Glioblastoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this research study is to test the safety and tolerability of the combination treatment of the investigational drugs vorinostat and pembrolizumab, in combination with chemotherapy (temozolomide), and radiotherapy. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers. However, both vorinostat and pembrolizumab are considered investigational drugs in this study because they are not approved for treatment of glioblastoma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX
Drug: Pembrolizumab · Drug: Vorinostat · Drug: Temozolomide · Radiation: Radiotherapy
100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Drug: Pembrolizumab · Drug: Vorinostat · Drug: Temozolomide · Radiation: Radiotherapy
200 mg intravenously (IV) every 3 weeks. The dose of pembrolizumab will remain the same throughout study treatment. During the maintenance phase, participants will receive pembrolizumab (for 12 months).
Also known as: Keytruda, immunotherapy
Dose Escalation Level -1 vorinostat 100 mg/day by mouth on days 1-5 every week during radiotherapy starting on first day of radiotherapy and 300 mg/day 1 week on 1 week off after radiotherapy. Level 1:vorinostat 200 mg/day by mouth on day 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 300 mg/day 1 week on 1 week off after radiotherapy. Dose Escalation Level 2: vorinostat 300 mg/day by mouth on days 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 400 mg/day 1 week on 1 week off after radiotherapy.
Also known as: Zolinza™, chemotherapy, histone deacetylase inhibitor
All participants will receive standard Temozolomide: Temozolomide (chemotherapy) 75 mg/m\^2/day by mouth administered during the course of radiotherapy. Temozolomide will be administered continuously from Day 1 of radiotherapy to the last day of radiation. Maintenance Phase: temozolomide will start 4 weeks (+/- 3 days) after last dose of radiotherapy and will continue for 6 cycles post radiotherapy (150-200 mg/m\^2/day, days 1-5 every 4 weeks) as per standard of care. During the maintenance phase, participants will receive Temozolomide (for the first 6 months).
Also known as: chemotherapy, Temodar, TMZ
All participants will receive standard radiotherapy: a total dose of 60 Gy administered in daily doses of 2 Gy, typically on a 5 days on / 2 days off schedule over 6 - 7 weeks.
Also known as: radiation therapy
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD)/recommended dose expansion dose of vorinostat given in combination with pembrolizumab, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma. Toxicities will be graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 for toxicity categories as outlined in the study protocol.
Time frame: 12 weeks
Overall Survival (OS)
Median overall survival rate, 95% confidence survival. OS: Time from randomization until death from any cause.
Time frame: Up to 24 months
| Milestone | Level -1 | Level 1 | Radiotherapy and Maintenance Phase |
|---|---|---|---|
| Started | 6 | 8 | 7 |
| Completed | 6 | 8 | 6 |
| Not completed | 0 | 0 | 1 |
The maximum tolerated dose (MTD)/recommended dose expansion dose of vorinostat given in combination with pembrolizumab, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma. Toxicities will be graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 for toxicity categories as outlined in the study protocol.
| mg/day Vorinostat | Dose Escalation Phase |
|---|---|
| MTD during RTX | 100 |
| MTD after RTX | 300 |
Median overall survival rate, 95% confidence survival. OS: Time from randomization until death from any cause.
| Months | Level -1 | Level 1 | Radiotherapy and Maintenance Phase |
|---|---|---|---|
| Overall Survival (OS) | NA (17.9 to NA) | 12.2 (10.7 to NA) | NA (16.2 to NA) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Level -1 | 3/6 (50%) | 2/6 (33.3%) | 6/6 (100%) |
| Level 1 | 5/8 (62.5%) | 6/8 (75%) | 8/8 (100%) |
| Radiotherapy and Maintenance Phase | 1/7 (14.3%) | 3/7 (42.9%) | 7/7 (100%) |
| Event | Level -1 | Level 1 | Radiotherapy and Maintenance Phase |
|---|---|---|---|
| SeizureNervous system disorders | 0/6 | 2/8 | 0/7 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/6 | 2/8 | 0/7 |
| Flu like symptomsGeneral disorders | 1/6 | 0/8 | 0/7 |
| Urinary tract infectionInfections and infestations | 0/6 | 0/8 | 1/7 |
| Alanine aminotransferase increasedInvestigations | 0/6 | 0/8 | 1/7 |
| HypotensionVascular disorders | 0/6 | 0/8 | 1/7 |
| Thromboembolic eventVascular disorders | 0/6 | 1/8 | 1/7 |
| NauseaGastrointestinal disorders | 0/6 | 0/8 | 1/7 |
| VomitingGastrointestinal disorders | 0/6 | 0/8 | 1/7 |
| Non-cardiac chest painGeneral disorders | 0/6 | 0/8 | 1/7 |
| Event | Level -1 | Level 1 | Radiotherapy and Maintenance Phase |
|---|---|---|---|
| Lymphocyte count decreasedInvestigations | 6/6 | 6/8 | 6/7 |
| Platelet count decreasedInvestigations | 6/6 | 6/8 | 6/7 |
| Investigations - Other, specifyInvestigations | 5/6 | 0/8 | 7/7 |
| AnemiaBlood and lymphatic system disorders | 5/6 | 4/8 | 6/7 |
| FatigueGeneral disorders | 5/6 | 5/8 | 4/7 |
| NauseaGastrointestinal disorders | 5/6 | 2/8 | 4/7 |
| VomitingGastrointestinal disorders | 5/6 | 2/8 | 3/7 |
| DiarrheaGastrointestinal disorders | 4/6 | 1/8 | 0/7 |
| White blood cell decreasedInvestigations | 3/6 | 3/8 | 4/7 |
| Creatinine increasedInvestigations | 2/6 | 1/8 | 4/7 |
Multiple dose levels are specified in the protocol but only the administered doses are included in the baseline characteristics.
| Age, Continuous(years) | Level -1 | Level 1 | Radiotherapy and Maintenance Phase | Total |
|---|---|---|---|---|
| Mean | 56.33 (36 to 67) | 60.38 (44 to 74) | 55.57 (32 to 77) | 57.62 (32 to 77) |
| Sex: Female, Male(Participants) | Level -1 | Level 1 | Radiotherapy and Maintenance Phase | Total |
|---|---|---|---|---|
| Female | 2 | 5 | 1 | 8 |
| Male | 4 | 3 | 6 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Level -1 | Level 1 | Radiotherapy and Maintenance Phase | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 2 | 2 |
| Not Hispanic or Latino | 5 | 7 | 5 | 17 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Level -1 | Level 1 | Radiotherapy and Maintenance Phase | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 5 | 7 | 5 | 17 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 2 |
| Region of Enrollment(participants) | Level -1 | Level 1 | Radiotherapy and Maintenance Phase | Total |
|---|---|---|---|---|
| United States | 6 | 8 | 7 | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Oct 2021, 43 months.
Results were first posted in Oct 2025, 3 years 11 months after primary completion.
Of 240 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's 43 months is close to that.
Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vorinostat
H. Lee Moffitt Cancer Center and Research Institute →