← Back to Search

Monoclonal Antibodies

Pembrolizumab + Temozolomide + TTFields for Glioblastoma (2-THE-TOP Trial)

Phase 2

Waitlist Available

Led By Ashley Ghiaseddin, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Steroid dose equivalent to dexamethasone dose of ≤ 4mg daily at the time of starting adjuvant treatment

Patients must be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 5 years

Awards & highlights

2-THE-TOP Trial Summary

This trial is testing whether adding pembrolizumab to the standard treatment for glioblastoma (surgery, radiation, and chemotherapy) can help patients live longer without their disease progressing.

Who is the study for?

Adults with newly diagnosed Glioblastoma who've had surgery and radiotherapy can join. They must be healthy enough for further treatment, have a life expectancy of at least 3 months, and use effective contraception. Those with certain other cancers, previous treatments like anti-PD-1 or bevacizumab, implanted electronic brain devices, severe allergies to trial drugs, uncontrolled illnesses or active infections cannot participate.Check my eligibility

What is being tested?

The study tests if adding Pembrolizumab (an immunotherapy drug) to Temozolomide chemotherapy and TTFields (Optune®), an electric field therapy, extends the time patients live without their brain cancer getting worse compared to past data.See study design

What are the potential side effects?

Possible side effects include immune system reactions that may affect organs; skin reactions from Optune device; fatigue; nausea from Temozolomide; increased risk of infection due to Pembrolizumab's effect on the immune system.

2-THE-TOP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am taking a low dose of steroids, not more than 4mg of dexamethasone daily.

Select...

I am 18 years old or older.

Select...

I am eligible for high dose temozolomide and Optune therapy after my main treatment.

Select...

I am able to care for myself but may not be able to do active work.

Select...

My blood tests show my organs and bone marrow are working well.

Select...

I've had the safest possible surgery and specific treatment for my brain tumor.

2-THE-TOP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival Between the Groups From Time of Enrollment

Secondary outcome measures

Augmentation of TTFields-initiated Glioma-specific Immune Reaction by Pembrolizumab

Number of Participants With Toxicities, Serious Adverse Events and/or Other Adverse Events Treated With Triple Combination Treatment

Overall Survival (OS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

2-THE-TOP Trial Design

2Treatment groups

Experimental Treatment

Group I: Optune System combined with Temozolomide (TMZ) + PembrolizumabExperimental Treatment3 Interventions

Patients with newly-diagnosed GBM who undergo maximal safe resection (biopsy alone is eligible) followed by chemoradiation consisting of concomitant TMZ daily and radiation therapy (RT) with minimal RT will be eligible for this trial. Four to six weeks after finishing chemoradiation, patients will start monthly cycles of adjuvant TMZ. Treatment with Optune will start at approximately the same time as the first cycle of adjuvant TMZ and continue until second disease progression or a maximum of 2 years. Within one week after starting Cycle 2 of adjuvant TMZ and Optune therapy, patients will begin open-label treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.

Group II: Historical ControlExperimental Treatment2 Interventions

Historical control of patients treated with Optune System combined with Temozolomide alone from the EF-14 study will be compared with the Optune System combined with Temozolomide (TMZ) + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Temozolomide (TMZ)

2005

Completed Phase 3

~760

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,665 Total Patients Enrolled

10 Trials studying Glioblastoma

443 Patients Enrolled for Glioblastoma

NovoCure Ltd.Industry Sponsor

57 Previous Clinical Trials

4,682 Total Patients Enrolled

28 Trials studying Glioblastoma

2,704 Patients Enrolled for Glioblastoma

Ashley Ghiaseddin, MDPrincipal InvestigatorUniversity of Florida

3 Previous Clinical Trials

36 Total Patients Enrolled

2 Trials studying Glioblastoma

24 Patients Enrolled for Glioblastoma

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03405792 — Phase 2

Glioblastoma Research Study Groups: Optune System combined with Temozolomide (TMZ) + Pembrolizumab, Historical Control

Glioblastoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03405792 — Phase 2

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03405792 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other pembrolizumab studies are available for review?

"Pembrolizumab is currently being studied in 1211 clinical trials, with 147 of those research programs in Phase 3. Although a large concentration of the studies are based in Houston, Texas, there are 40817 total locations running Pembrolizumab trials."

Answered by AI

Does this trial differ significantly from other trials of its type?

"Pembrolizumab has been studied since 2002. The initial study was completed in 2002 and was sponsored by Schering-Plough. Following the first study in 2002, which involved 60 participants, Pembrolizumab received its Phase 2 drug approval. Today there are 1211 live trials for Pembrolizumab across 3098 cities and 64 countries."

Answered by AI

Are there any unfilled positions in this experiment for test subjects?

"Unfortunately, the clinical trial is not recruiting patients at this time. According to the information found on clinicaltrials.gov, which was last updated on October 20th, 2022, the study has not been actively seeking participants since it was first posted on February 23rd, 2018. Although this particular trial may not be enrolling patients presently, there are 1669 other trials with open recruitment across various medical centres."

Answered by AI

How many guinea pigs are we looking for in this experiment?

"This clinical trial is not currently recruiting patients. The information was originally posted on February 23rd, 2018 and was most recently edited on October 20th, 2022. However, there are other 458 trials actively searching for participants with glioblastoma and 1211 trials for Pembrolizumab that are enrolling patients."

Answered by AI

What is the minimum age requirement for this clinical trial?

"The age limit for this clinical trial is 80 years old. All participants must be above the age of 18."

Answered by AI

What are some of the conditions that Pembrolizumab has been known to treat?

"Pembrolizumab is most frequently used as a treatment for cancer. However, it can also be taken to treat other conditions such as unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."

Answered by AI

Is Pembrolizumab a safe medication for patients to take?

"Pembrolizumab falls into the Phase 2 category, which suggests that while there is evidence of its safety, more research is needed to support claims of efficacy. Consequently, our team has given it a score of 2."

Answered by AI

How can I become a part of this medical research project?

"This study is looking for 31 patients with glioblastoma aged 18 and 80. Most notable, applicants must meet the following criteria: Gliadel wafers placement at the time of surgical resection is allowed., Histologic confirmation of glioblastoma, WHO Grade IV (GBM variants are allowed; Lower grade gliomas that have been transformed to GBM will be considered newly diagnosed GBM if the lower-grade tumor was not previously treated, and the standard treatment for GBM including radiation and temozolomide is now planned)., MGMT methylation status if available (indeterminate"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)

2018. "Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03405792.

All > Recurrent Glioblastoma > Glioblastoma Multiforme