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Trial Title:
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT ID:
NCT06556563
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Pembrolizumab
Temozolomide
Conditions: Keywords:
TTFields
Pembrolizumab
Glioblastoma
Tumor Treating Fields
Immunotherapy
Merck Sharp & Dohme LLC
GBM
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The participants in the study will be randomized in a ratio of 2:1 in favor of the
treatment group to one of the following groups:
Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab.
Control Group - Optune concomitant with maintenance TMZ and placebo.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Optune® device
Description:
Optune® device delivering TTFields therapy at 200 kHz.
Arm group label:
Control Group
Arm group label:
Treatment Group
Other name:
TTFields
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Temozolomide per approved labeling.
Arm group label:
Control Group
Arm group label:
Treatment Group
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Arm group label:
Treatment Group
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35
cycles.
Arm group label:
Control Group
Summary:
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of
Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ)
chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ
and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the
study is to evaluate the Overall Survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The participant (or legally acceptable representative) has provided documented
informed consent for the study.
2. Be ≥ 18 years of age on day of providing informed consent.
3. Participant with new diagnosis of GBM according to World Health Organization (WHO)
2021 Classification.
4. Recovered from maximal debulking surgery (gross total resection, partial resection
and biopsy-only patients are all acceptable), Gliadel wafers placement at the time
of surgical resection is allowed.
5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to
local practice (56-64 Gy), and concomitant TMZ chemotherapy.
6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m^2
daily x 5, Q28 days).
7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
assessed within 7 days before randomization.
8. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for
the last 7 days prior to randomization, if applicable.
Exclusion Criteria:
1. Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti-
Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2
(PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40,
CD137).
2. Ongoing requirement for >2 mg dexamethasone (or equivalent), due to intracranial
mass effect.
3. Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks prior to randomization.
4. Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
5. Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first study
treatment.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study medication.
Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
8. Early progressive disease after the end of TMZ/RT. If pseudo progression is
suspected, additional imaging studies should be performed to rule out true
progression.
9. Infratentorial or leptomeningeal disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UF Health Neuromedicine
Address:
City:
Gainesville
Zip:
32608
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Ghiaseddin
Email:
ashley.ghiaseddin@neurosurgery.ufl.edu
Facility:
Name:
Swedish Medical Center
Address:
City:
Seattle
Zip:
98122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Loreen
Phone:
206-320-7121
Email:
alipi.bonm@swedish.org
Start date:
November 2024
Completion date:
April 2029
Lead sponsor:
Agency:
NovoCure GmbH
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
NovoCure Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06556563
