Trial Outcomes & Findings for Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) (NCT NCT03405792)

Last Updated: 2025-10-28

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Assessed up to 24 months

Results posted on

2025-10-28

Participant Flow

Recruitment began in 2018 and lasted until July 2021. Patients with newly diagnosed GBM who completed standard of care radiation therapy together with concomitant TMZ were recruited. Neuro-oncologists identified subjects as part of routine clinical care. Patients with newly-diagnosed GBM who underwent maximal safe resection followed by chemoradiation consisting of concomitant TMZ 75mg/m2 daily and RT with minimal RT dose of 40gy were eligible for this trial.

Four to 6 weeks post- chemoradiation, patients began monthly cycles of adjuvant TMZ (minimum 6 and maximum 12 cycles of adjuvant TMZ) and treatment with Optune. Patients began treatment with pembrolizumab no sooner than 3 weeks after starting Optune therapy. Forty participants were consented. Nine were deemed ineligible. Five who were eligible to participate withdrew or were withdrawn because they did not start or discontinued Optune or did not receive pembrolizumab.

Participant milestones

Participant milestones
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control Historical control data of patients treated with Optune System combined with Temozolomide alone will be compared with the Optune System combined with Temozolomide (TMZ) + Pembrolizumab arm. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy.
Overall Study STARTED	31	466
Overall Study COMPLETED	26	466
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control Historical control data of patients treated with Optune System combined with Temozolomide alone will be compared with the Optune System combined with Temozolomide (TMZ) + Pembrolizumab arm. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy.
Overall Study o Did not start or discontinued TTF during cycle 1 of TMZ for personal reasons	4	0
Overall Study o Did not receive pembrolizumab	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab n=31 Participants 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control n=466 Participants 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	Total n=497 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	377 Participants n=7 Participants	399 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	89 Participants n=7 Participants	98 Participants n=5 Participants
Age, Continuous	60.5 years n=5 Participants	56 years n=7 Participants	NA years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	150 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	316 Participants n=7 Participants	338 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	447 Participants n=7 Participants	477 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	416 Participants n=7 Participants	444 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	221 participants n=7 Participants	252 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to 24 months

Outcome measures

Outcome measures
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab n=26 Participants 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control n=466 Participants 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
Progression-free Survival Between the Groups From Time of Enrollment	11.79 months Interval 8.71 to 22.72	6.7 months Interval 6.1 to 8.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab n=26 Participants 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control 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
Number of Participants With Toxicities, Serious Adverse Events and/or Other Adverse Events Treated With Triple Combination Treatment	26 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Optune System Combined With Temozolomide (TMZ) + Pembrolizumab

Serious events: 18 serious events

Other events: 28 other events

Deaths: 25 deaths

Historical Control Optune System Combined With Temozolomide (TMZ)

Serious events: 0 serious events

Other events: 218 other events

Deaths: 265 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Optune System Combined With Temozolomide (TMZ) + Pembrolizumab n=28 participants at risk 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. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.	Historical Control Optune System Combined With Temozolomide (TMZ) n=456 participants at risk Historical control of patients treated with Optune System combined with Temozolomide alone from the EF-14 study based on data published by Stupp et al, 2017.
Gastrointestinal disorders Gastrointestinal Disorders	78.6% 22/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	5.0% 23/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Blood and lymphatic system disorders Blood and Bone Marrow	32.1% 9/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	12.9% 59/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Infections and infestations Infections	39.3% 11/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	7.0% 32/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	35.7% 10/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	5.3% 24/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Metabolism and nutrition disorders Metabolism	10.7% 3/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	3.5% 16/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal	67.9% 19/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	4.6% 21/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Nervous system disorders Nervous System Disorders	75.0% 21/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	23.9% 109/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Respiratory, thoracic and mediastinal disorders Respiratory	28.6% 8/28 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.	5.3% 24/456 • Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab. Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.

Additional Information

Ashley Ghiaseddin, MD

University of Florida

Phone: 352-273-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place