Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03405792 : Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (OptuneĀ®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
PhasePhase 2
AgesMin: 18 Years Max: 80 Years
Eligibility
Inclusion Criteria:

- 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 methylation status will be
considered unmethylated).

- Karnofsky performance status (KPS) =70%.

- Patients must be at least 18 years of age.

- Received maximal safe resection (biopsy only allowed) and radiotherapy concomitant
with temozolomide:

1. Gliadel wafers placement at the time of surgical resection is allowed.

2. Any additional treatment directed at GBM will be considered exclusionary.

3. Minimum dose for concomitant radiotherapy is 40 Gy.

- Candidate for adjuvant high dose temozolomide and Optune therapy.

- Life expectancy of at least 3 months.

- Adequate bone marrow and organ function as defined below:

1. ANC = 1,500/mcL

2. Platelets = 100,000/mcL

3. Hemoglobin = 9 g/dL or = 5.6 mmol/L (transfusion is allowed)

4. Serum creatinine = 1.5 x IULN OR creatinine clearance by Cockcroft-Gault = 60
mL/min for patients with serum creatinine > 1.5 x IULN

5. Serum total bilirubin = 1.5 x IULN OR direct bilirubin = IULN for patients with
total bilirubin > 1.5 x IULN

6. AST (SGOT) and ALT (SGPT) = 3 x IULN

- Participants of childbearing age must use effective contraception:

- Women of childbearing potential (WOCBP) must be using a highly effective method
of contraception to avoid pregnancy throughout the study and for at least 24
weeks after the last dose of study drug to minimize the risk of pregnancy. Prior
to study enrollment, women of childbearing potential must be advised of the
importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy. Refer to Appendix D for guidance on
highly effective contraceptive methods.

- WOCBP include any woman who has experienced menarche and who has not undergone
successful surgical sterilization (hysterectomy, bilateral tubal ligation or
oophorectomy) or who is not post-menopausal. Post-menopause is defined as:

- Amenorrhea that has lasted for = 12 consecutive months without another cause, or

- For women with irregular menstrual periods who are taking hormone replacement
therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of
greater than 35 mIU/mL.

- Males with female partners of childbearing potential must agree to use
physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)
throughout the study and should avoid conceiving children for 24 weeks following
the last dose of study drug.

- Ability of the patient or their legally authorized representative (LAR) to understand
and willingness to sign an IRB approved written informed consent document

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

- Optune and temozolomide treatment start date will be at least 4 weeks but not more
than 6 weeks from the later of last dose of concomitant temozolomide or radiotherapy.
Although Optune and temozolomide should be started simultaneously, it is not required
as long as both are started within this time frame

Exclusion Criteria:

- Prior treatment with anti-angiogenic agents including bevacizumab.

- History of malignancy (other than glioblastoma) during the last two years except
non-melanoma skin cancer, in situ cervical cancer, indolent neoplasm not requiring
active treatment, or cured, early-stage prostate cancer not requiring active treatment
or treated with local treatment only.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways).

- Progressive disease (according to RANO criteria). Advanced imaging is allowed to
further investigate suspected pseudoprogression if deemed necessary.

- Actively participating in another clinical treatment trial intended to treat GBM.

- Multifocal gliomas defined as distinct tumors that do not have overlapping T2/FLAIR
signal.

- Presence of leptomeningeal metastases.

- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
implanted electronic devices in the brain, or documented clinically significant
arrhythmias.

- Tumor is entirely located in the infra-tentorial region.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03405792      |      Link to official Clinicaltrials.gov listing
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