NCT07326566RecruitingPhase 2
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 5 May 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Black Diamond Therapeutics, Inc.
- Diseases
- Glioblastoma
- NCT number
- NCT07326566
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 162
- From 5 May 2026 to the primary completion date, Nov 2028
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progression of GBM prior to Enrollment, Screening, or Randomization.
- Biopsy-only/no resectional surgery.
Other illness
- Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
- Significant other uncontrolled health conditions or other malignancies.
Lab values
- 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.
Other
- Intent to use Optune® (TTF).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Piedmont Oncology Research Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins Sidney Kimmel Cancer Center - Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Alabama at Birmingham O'Neal Comprehensive Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Cleveland Clinic Taussig Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Henry Ford Cancer- Detroit Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Prisma Health Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| UCSD Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Northwell Health Center for Advanced Medicine - Brain Tumor Center Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Atrium Health Levine Cancer Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Rutgers Cancer Institute Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Maine Health Cancer Care and Blood Disorders - Scarborough Coordinator of this site? Confirm its status | Scarborough | United States | Recruiting |
| Highlands Oncology Group Coordinator of this site? Confirm its status | Springdale | United States | Recruiting |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Atlantic Health Coordinator of this site? Confirm its status | Summit | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Johns Hopkins Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Atrium Health Wake Forest Baptist Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.