Trial · NCT03405792
Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
NCT03405792, Phase 2, Active not recruiting, University of Florida; results first posted 2024-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP). Trials, record NCT03405792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03405792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
- NCT number
- NCT03405792
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Glioblastoma, Glioblastoma, WHO Grade IV
- Interventions
- Temozolomide (TMZ), Optune System, Pembrolizumab
- First posted
- 2018-01-23
- Last updated
- 2026-02-06
- Results first posted
- 2024-04-15
- Limitations and caveats
Limitation 1: We do not have the distribution of ages for the historical control arm to determine the median for the total population.~Limitation 2: Adverse Events for historical controls were monitored/assessed/reported without regard to the specific Adverse Event Term therefore we are not reporting for the historical control arm.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Between the Groups From Time of Enrollment | Assessed up to 24 months | Time from enrollment to progression or death or censoring, whichever occurs first. The study team will use the one-sample log-rank test to compare PFS in the triple combination arm relative to the historical control arm to determine whether the triple combination treatment increases PFS in newly diagnosed GBM patients when compared to TTFields+TMZ historical control patients from the EF-14 study. Evaluability for progression free survival required participants to receive adjuvant TMZ, Optune and at least 1 dose of pembrolizumab. |
| Secondary | Number of Participants With Toxicities, Serious Adverse Events and/or Other Adverse Events Treated With Triple Combination Treatment | Assessed up to 24 months | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting for grade 3 or higher. We will estimate proportions and 95% confidence intervals for patients in the triple combination arm who experience toxicities and other types of AEs and serious AEs. |
| Secondary | Overall Survival (OS) | Assessed up to 5 years | Time from enrollment to death or censoring, whichever occurs first. We will use the log-rank test to compare OS between the triple combination arm relative to the historical control arm. |
| Secondary | Augmentation of TTFields-initiated Glioma-specific Immune Reaction by Pembrolizumab | Assessed up to 24 months | We will use mixed effect regression to assess changes in response variables related to glioma-specific immune reaction before, during, and after treatment with pembrolizumab. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Between the Groups From Time of Enrollment | Assessed up to 24 months | months | MEDIAN | |
| SECONDARY | Number of Participants With Toxicities, Serious Adverse Events and/or Other Adverse Events Treated With Triple Combination Treatment | Assessed up to 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | Assessed up to 5 years | |||
| SECONDARY | Augmentation of TTFields-initiated Glioma-specific Immune Reaction by Pembrolizumab | Assessed up to 24 months |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Between the Groups From Time of Enrollment | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 11.79 | 95% Confidence Interval 8.71 to 22.72 | months | |
| Progression-free Survival Between the Groups From Time of Enrollment | Historical Control | 6.7 | 95% Confidence Interval 6.1 to 8.1 | months | |
| Number of Participants With Toxicities, Serious Adverse Events and/or Other Adverse Events Treated With Triple Combination Treatment | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 26 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 31 | |
| Overall Study | STARTED | Historical Control | 466 | |
| Overall Study | COMPLETED | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 26 | |
| Overall Study | COMPLETED | Historical Control | 466 | |
| Overall Study | NOT COMPLETED | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 5 | |
| Overall Study | NOT COMPLETED | Historical Control | 0 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal Disorders | Gastrointestinal disorders | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 22 | 28 | |
| other | Gastrointestinal Disorders | Gastrointestinal disorders | Historical Control Optune System Combined With Temozolomide (TMZ) | 23 | 456 | |
| other | Blood and Bone Marrow | Blood and lymphatic system disorders | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 9 | 28 | |
| other | Blood and Bone Marrow | Blood and lymphatic system disorders | Historical Control Optune System Combined With Temozolomide (TMZ) | 59 | 456 | |
| other | Infections | Infections and infestations | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 11 | 28 | |
| other | Infections | Infections and infestations | Historical Control Optune System Combined With Temozolomide (TMZ) | 32 | 456 | |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 10 | 28 | |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Historical Control Optune System Combined With Temozolomide (TMZ) | 24 | 456 | |
| other | Metabolism | Metabolism and nutrition disorders | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 3 | 28 | |
| other | Metabolism | Metabolism and nutrition disorders | Historical Control Optune System Combined With Temozolomide (TMZ) | 16 | 456 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 25 | 28 |
| Total, all-cause mortality | Historical Control Optune System Combined With Temozolomide (TMZ) | 265 | 466 |
| Total, other adverse events | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 28 | 28 |
| Total, other adverse events | Historical Control Optune System Combined With Temozolomide (TMZ) | 218 | 456 |
| Total, serious adverse events | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | 18 | 28 |
| Total, serious adverse events | Historical Control Optune System Combined With Temozolomide (TMZ) | 0 | 456 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40466642 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Optune System Combined With Temozolomide (TMZ) + Pembrolizumab vs Historical Control Optune System Combined With Temozolomide (TMZ): deaths from any cause | Trial comparisons |
| Optune System Combined With Temozolomide (TMZ) + Pembrolizumab vs Historical Control Optune System Combined With Temozolomide (TMZ): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03405792
GET https://conductscience.org/api/trials/v1/NCT03405792/events?page=2