Glioblastoma (GBM)Phase 2NCT07326566
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
A Phase 2 study testing silevertinib in combination with temozolomide and temozolomide (TMZ) in people with Glioblastoma (GBM) and Newly Diagnosed Glioblastoma, run by Black Diamond Therapeutics, Inc. at 35 sites in United States.
Trial summary
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM
- What is being tested?
- silevertinib in combination with temozolomide and temozolomide (TMZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 35 sitesUnited States
- Study dates
- 5 May 2026to Mar 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).
- Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).
- For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
- For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.
- For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.
- No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.
- At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.
Who cannot join
- Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
- Progression of GBM prior to Enrollment, Screening, or Randomization.
- Biopsy-only/no resectional surgery.
- Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.
- Intent to use Optune® (TTF).
- Significant other uncontrolled health conditions or other malignancies.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Black Diamond Therapeutics Clinical Trial Navigation Service contact
35 sites in 1 country
United States35 sites, 35 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Cancer Answer Line, 800-865-1125, CancerAnswerLine@med.umich.edu
- Recruiting
Piedmont Oncology Research
Atlanta, Georgia, 30318
Jeff Whorton, 770-630-9299, Jeff.Whorton@piedmont.org
- Recruiting
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore
Baltimore, Maryland, 21287
Solmaz Sahebjam, MD, 202-660-6500, ssahebj1@jh.edu
- Recruiting
University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, 35233
Staci Hankins, 205-644-9891, sshea@uabmc.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Isabel Arrillaga-Romany, 617-724-8770, iarrillaga@mgh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Ka-Wai Ho, MD, 617-667-2100, Kho5@bidmc.harvard.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Kathryn Partridge, 508-340-0348, Kathryn_Partridge@DFCI.HARVARD.EDU
- Recruiting
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Rachel Hufsey, 216-442-6671, HUFSEYR@ccf.org
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Jake Lanning, 614-685-2435, Jake.Lanning@osumc.edu
- Recruiting
Henry Ford Cancer- Detroit
Detroit, Michigan, 48202
Meghan Gauronskas, RN, (866) 955-4397, mgauron1@hfhs.org
Nicole Beck, (866) 955-4397, nbeck2@hfhs.org
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Stephanie Van Bebber, 571-472-4724, Stephanie.VanBebber@inova.org
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Kim Williams, 864-522-431, Kim.Williams3@Prismahealth.org
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Mohammed Nassfi, (866) 955-4397, mnassif@mdanderson.org
- Recruiting
UCSD Moores Cancer Center
La Jolla, California, 92037-0845
Sheila Medina, (866) 955-4397, s4medina@health.ucsd.edu
- Recruiting
Northwell Health Center for Advanced Medicine - Brain Tumor Center
Lake Success, New York, 11042
Center for Advanced Medicine - Brain Tumor Center, 516-253-7753, neurosurgeryresearch@northwell.edu
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Shannon Cyhan, RN, BSN, CCRC, 310-248-7855, shannon.cyhan@cshs.org
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
UW Cancer Connect, (866) 955-4397, cancerconnect@uwhealth.org
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Anais Vega, 786-527-8861, Anais.Vega@baptisthealth.net
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Xiaoru Chen, (866) 955-4397, xc194@cinj.rutgers.edu
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
Amy Rodrigues, 203-260-9632, amy.rodrigues@yale.edu
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Research Nurse Navigator, 212-342-5162, Cancerclinicaltrials@cumc.columbia.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68106
Michaela Savine, 402-836-9488, misavine@unmc.edu
- Recruiting
UC Irvine Health
Orange, California, 92868
Manisha Dandekar, (866) 955-4397, mdandeka@hs.uci.edu
- Recruiting
Stanford University
Palo Alto, California, 94304
Kelly Tanner, 650-724-5361, secure-sci-cto-neuro-crcs@lists.stanford.edu
- Recruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, 19107
Community Research Operations & Enrollment, 215-600-9151, ONCTrialNow@jefferson.edu
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Linda Elias, 412-623-6037, eliaslj@upmc.edu
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Keara Mackey, 804-628-1894, mackeyka@vcu.edu
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Renee Feast, 479-878-7004, rfeast@hogonc.com
- Recruiting
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63108
Kelsey Etter, 314-273-0656, etter@wustl.edu
- Recruiting
Atlantic Health
Summit, New Jersey, 07901
Samantha Caulfield, RN, 908-598-6561, Samantha.caulfield@atlantichealth.org
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Carie Bliss, 813-745-2131, Carie.Bliss@moffitt.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Yoko Eng, 718-405-8516, yeng@montefiore.org
- Recruiting
Johns Hopkins Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Solmaz Sahebjam, MD, 202-660-6500, ssahebj1@jh.edu
About this study
Official title: A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.
Specifically, this study is being done to find answers to the following questions:
- How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?
- What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?
- Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?
Read the detailed description
Silevertinib was designed to block a growth signal important to some cancers where tumors grow because of changes in a protein called epidermal growth factor receptor (EGFR). These changes are called gene amplifications, mutations, or alterations and are found in tumors. Temozolomide is a drug that fights cancer cells by damaging DNA (the genetic material of cells), which could cause the tumor cells to die. It is the standard treatment for adults with certain types of newly diagnosed brain cancer, like GBM. It is given together with radiotherapy and sometimes afterward as maintenance therapy.
This study has 2 parts. To be eligible for the study, participants must have received a diagnosis of GBM, had surgery to remove or reduce the size of the tumor, and received adjuvant radiation therapy and temozolomide. No other prior treatments for GBM are allowed.
In Part 1 (called the Safety Lead-in), participants will receive silevertinib combined with temozolomide to determine if the combination is safe and to find the best dose. Approximately 12 participants are expected to enroll in Part 1 of the study.
In Part 2, all participants will be randomized to one of two different treatment groups:
- Group 1: Silevertinib + temozolomide
- Group 2: Temozolomide only
Approximately 150 participants are expected to be randomized in Part 2 of the study.
In both Part 1 and Part 2, the study treatment will be given in "cycles". Each cycle will be 28 days. After a cycle ends, the next cycle will immediately begin the next day. Both silevertinib and temozolomide will be taken orally. Silevertinib is taken daily until disease progression and temozolomide is taken for the first 5 days of each cycle (up to 6 cycles).
If participants are found to be eligible for the study and enrolled (in Part 1) or randomized (in Part 2), participants will:
- Take the study drug as directed
- Return for frequent clinic visits to monitor overall health and status of GBM
- Undergo imaging and other laboratory tests to determine status of GBM
- Complete a paper diary at home to record the date and time(s) that the study drug is taken
- Conditions
- Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM), Glioma, Central Nervous System Diseases
- Being tested
- silevertinib in combination with temozolomide, temozolomide (TMZ)
- Keywords
- EGFR, Glioblastoma, Unmethylated, Unmethylated MGMT promoter, Newly Diagnosed, temozolomide, Temodar, silevertinib, BDTX-1535, EGFR alterations, epidermal growth factor receptor, EGFRvIII, epidermal growth factor receptor (EGFR)
- Medical subject headings
- Glioblastoma, Glioma, Central Nervous System Diseases, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silevertinib in combination with temozolomideDrug
Also called BDTX-1535, Temodar, TMZ
Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles.
temozolomide (TMZ)Drug
Also called TMZ, Temodar
Participants randomized to Arm B will receive temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| silevertinib and temozolomide | Experimental | silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles Receives: Drug: silevertinib in combination with temozolomide |
| temozolomide | Active comparator | temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles Receives: Drug: temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
Measured: 12 months
Secondary outcomes (1)
Overall Survival
Overall survival defined as time from first dose of study drug to death from any cause.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start5 May 2026
- Primary completionNov 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Black Diamond Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326566
- Sponsor's protocol ID
- BDTX-1535-201
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No