Recruiting

Phase 2

Silevertinib & TemozolomideStudy of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

Sponsor:

Black Diamond Therapeutics, Inc.

Code:

NCT07326566

Conditions

Glioblastoma (GBM)

Newly Diagnosed Glioblastoma

GBM

Glioblastoma Multiforme (GBM)

Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

silevertinib in combination with temozolomide

temozolomide (TMZ)

Study Details

Brief 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.

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?

Conditions

Glioblastoma (GBM)

Newly Diagnosed Glioblastoma

GBM

Glioblastoma Multiforme (GBM)

Glioma

Study ID

NCT07326566

Start date

May 5, 2026

Status verified date

May, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: silevertinib and temozolomide

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

active comparator: temozolomide

temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles

Interventions

silevertinib in combination with temozolomide

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)

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

Primary outcome measure

Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Black Diamond Therapeutics Clinical Trial Navigation Service

(866) 955-4397 blackdiamondtx@careboxhealth.com

Locations

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Staci Hankins

205-644-9891 sshea@uabmc.edu

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Renee Feast

479-872-8130 sfarrow@hogonc.com

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Shannon Cyhan, RN, BSN, CCRC

310-248-7855 shannon.cyhan@cshs.org

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kelly Tanner

650-724-5361 secure-sci-cto-neuro-crcs@lists.stanford.edu

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Amy Rodrigues

203-260-9632 amy.rodrigues@yale.edu

Johns Hopkins Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Solmaz Sahebjam, MD

202-660-6500 ssahebj1@jh.edu

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Anais Vega

786-527-8861 Anais.Vega@baptisthealth.net

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Carie Bliss

813-745-2131 Carie.Bliss@moffitt.org

Piedmont Oncology Research

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Jeff Whorton

770-630-9299 Jeff.Whorton@piedmont.org

Johns Hopkins Sidney Kimmel Cancer Center - Baltimore

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Solmaz Sahebjam, MD

202-660-6500 ssahebj1@jh.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Isabel Arrillaga-Romany

617-724-8770 iarrillaga@mgh.harvard.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Ka-Wai Ho, MD

617-667-2100 Kho5@bidmc.harvard.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Amanda Dresser

(866) 955-4397 Amanda_Dresser@dfci.harvard.edu

Henry Ford Cancer- Detroit

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Meghan Gauronskas, RN

(866) 955-4397 mgauron1@hfhs.org

Nicole Beck

(866) 955-4397 nbeck2@hfhs.org

Washington University School of Medicine Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Kelsey Etter

314-273-0656 etter@wustl.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68106

Contacts

Michaela Savine

402-836-9488 misavine@unmc.edu

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Oﬃce

551-996-1777 OncologyResearchReferral@hmhn.org

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Xiaoru Chen

(866) 955-4397 xc194@cinj.rutgers.edu

Atlantic Health

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Samantha Caulfield, RN

908-598-6561 Samantha.caulfield@atlantichealth.org

Northwell Health Center for Advanced Medicine - Brain Tumor Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Center for Advanced Medicine - Brain Tumor Center

516-253-7753 neurosurgeryresearch@northwell.edu

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Research Nurse Navigator

212-342-5162 Cancerclinicaltrials@cumc.columbia.edu

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Yoko Eng

718-405-8516 yeng@montefiore.org

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rachel Hufsey

216-442-6671 HUFSEYR@ccf.org

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jake Lanning

614-685-2435 Jake.Lanning@osumc.edu

Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Community Research Operations & Enrollment

215-600-9151 ONCTrialNow@jefferson.edu

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Linda Elias

412-623-6037 eliaslj@upmc.edu

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Kim Williams

864-522-431 Kim.Williams3@Prismahealth.org

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

801-585-0115 rachel.kingsford@hci.utah.edu

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Stephanie Van Bebber

571-472-4724 Stephanie.VanBebber@inova.org

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Keara Mackey

804-628-1894 mackeyka@vcu.edu

More Information

Sponsor

Black Diamond Therapeutics, Inc.

Last update posted

Sep 16, 2026

Last verified

May, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Black Diamond Therapeutics, Inc. on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.