RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Black Diamond Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07326566

Registry updated: 2026-10-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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?

Interventions

silevertinib in combination with temozolomide (Drug)
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)
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

Eligibility criteria

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.

Conditions

Glioblastoma (GBM) Newly Diagnosed Glioblastoma GBM Glioblastoma Multiforme (GBM) Glioma Central Nervous System Diseases Brain Cancer

Locations

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham, Alabama, United States
Highlands Oncology Group — Springdale, Arkansas, United States
UCSD Moores Cancer Center — La Jolla, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
UC Irvine Health — Orange, California, United States
Stanford University — Palo Alto, California, United States
Yale Cancer Center — New Haven, Connecticut, United States
Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
Miami Cancer Institute — Miami, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Piedmont Oncology Research — Atlanta, Georgia, United States
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Henry Ford Cancer- Detroit — Detroit, Michigan, United States
Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
Rutgers Cancer Institute — New Brunswick, New Jersey, United States
Atlantic Health — Summit, New Jersey, United States
Northwell Health Center for Advanced Medicine - Brain Tumor Center — Lake Success, New York, United States
Columbia University Irving Medical Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Ohio State University — Columbus, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center — Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Prisma Health — Greenville, South Carolina, United States
UT MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States
Inova Schar Cancer Institute — Fairfax, Virginia, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment