Silevertinib with Temozolomide for Newly Diagnosed GBM
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Recruiting
Phase 2Interventional Study
Glioblastoma (GBM)Newly Diagnosed GlioblastomaGBMGlioblastoma Multiforme (GBM)GliomaCentral Nervous System DiseasesBrain Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
Black Diamond Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for people who have recently been diagnosed with glioblastoma, a type of brain cancer. Participants will receive a combination of two medications after surgery and radiation to see if it helps them live longer without the disease returning.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with glioblastoma.
I have a specific type of EGFR positive brain tumor.
I have not received any treatment for my glioblastoma other than surgery and radiation.
It has been at least 4 weeks since my radiation therapy finished.
My post-radiation MRI shows no disease progression.
You may not be able to join if
I have recurrent or spreading glioblastoma.
My glioblastoma has progressed before joining the trial.
I have only had a biopsy and no surgical removal of the tumor.
I have previously received treatment for glioblastoma with certain medications.
I plan to use Optune® (TTF).
I have other serious health problems or other types of cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 p…
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?
Trial Locations
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City
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Status
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 …
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.
Contacts
Black Diamond Therapeutics Clinical Trial Navigation Service
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