High Grade GliomaPhase 2BRAFNCT03973918
Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
A Phase 2 study testing Encorafenib, Binimetinib and Research Bloods in people with High Grade Glioma and BRAF V600E, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
Trial summary
The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma, BRAF V600E, BRAF V600K
- What is being tested?
- Encorafenib, Binimetinib and Research Bloods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2019to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients receiving any other standard or investigational agents are ineligible.
- Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
- Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by MRI imaging within 30 days of starting treatment.
- The following intervals from previous treatments are required to be eligible:
- 12 weeks from the completion of radiation.
- 16 weeks from an anti-VEGF therapy
Show all 19Show fewer
- 4 weeks from a nitrosourea chemotherapy
- 3 weeks from a non-nitrosourea chemotherapy
- 2 weeks or 5 half-lives from any investigational (not FDA-approved) agents
- 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
- Patients must be 18 years of age or older.
- Patients must have a Karnofsky Performance (KPS) Status ≥ 60%
- Patients must have adequate organ and marrow function within 30 days of starting treatment.
- Patients must be able to provide written informed consent.
- Women of childbearing potential must have a negative serum pregnancy test prior to study start. Women of childbearing potential must agree to use adequate contraception (intrauterine device, barrier, or other non-hormonal method of birth control; or abstinence) and not to donate ova from screening through 30 days after the last dose of study drug. Male participants must also agree to use adequate contraception and not to donate sperm from screening until 90 days after the last dose of study drug.
- Patients must be maintained on a stable or decreasing dose of systemic corticosteroid regimen (no increase for 5 days) prior to baseline MRI. Topical and inhaled steroid treatment is allowed.
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with other malignancies must be disease-free for ≥ 2 years.
- Patients must be able to swallow tablets and capsules.
- Patients must have a tumor tissue form completed and signed by a pathologist (see Section 9.6.4). The tumor tissue form must indicate availability of archived tissue. The archived tissue should be from the most recent tumor resection, demonstrating active tumor when sufficient tissue is available. If sufficient tissue is not available from the most recent surgery, then tissue from an earlier surgery is acceptable, if available, including from the initial resection at diagnosis.
Who cannot join
- Patients receiving any other standard or investigational agents are ineligible.
- Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
- Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients
- Current use of a prohibited medication (including herbal medications, supplements, or foods), or use of a prohibited medication ≤ 7 days prior to the start of study treatment.
- Patient has not recovered to ≤ Grade 1 non-hematologic toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll.
- Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:
Show all 22Show fewer
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) ≤ 180 days prior to start date;
- Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
- Left ventricular ejection fraction (LVEF) < 50% as determined by MUGA or ECHO;
- Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;
- History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
- Triplicate average baseline QTc interval ≥ 480 ms.
- Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (≤ 90 days) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.
- History of recent (≤ 90 days) thromboembolic or cerebrovascular event such as transient ischemic attack, cerebrovascular accident, or hemodynamically significant (massive or sub-massive) deep vein thrombosis or pulmonary emboli (DVT/PE). Note: Patients with DVT/PE that does not result in hemodynamic instability may enroll as long as they are anticoagulated for at least 4 weeks. Note: Patients with DVT/PE related to indwelling catheters or other procedures may enroll.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
- Pregnant women are excluded from this study because the effects of encorafenib and/or binimetinib on a fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with encorafenib or binimetinib, breastfeeding should be discontinued if the mother is treated with encorafenib and/or binimetinib.
- Patients who previously received BRAF or MEK inhibitors are excluded (including but not limited to dabrafenib, vemurafenib, encorafenib, sorafenib, trametinib, binimetinib, cobimetinib, or selumetinib).
- Patients will be excluded if their tumor harbors a known RAS activating mutation. This does not need to be specifically tested for eligibility.
- 3.4 Additional Inclusion Criteria for Surgical Arm
- Patients must meet the above inclusion / exclusion criteria for consideration with one exception. Patients with a BRAF-V600 E or K mutated low-grade glioma for whom there is a strong clinical suspicion of progression to high-grade would also be eligible for this arm. Additionally:
- Patients must have a clinical indication for a tumor surgery.
- No a priori contraindication to biospecimen collection (blood, tumor, CSF).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294-3410
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Study of Binimetinib in Combination With Encorafenib in Adults With Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor
The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors.
Read the detailed description
Primary Objective Estimate the efficacy of combination treatment with encorafenib and binimetinib, as measured by response rate (RANO criteria), in patients with recurrent BRAF V600E/K-mutated malignant glioma (MG) and anaplastic pleomorphic xanthoastrocytoma (PXAs).
Secondary Objectives
- Estimate efficacy as measured by progression-free survival in subjects with recurrent malignant glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.
- Evaluate duration of response in subjects who have a partial or complete response.
- Quantify the time-to-response among subjects who have a radiologic response.
- Estimate efficacy as measured by overall survival in subjects with recurrent malignant glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.
- Characterize the toxicity profile of the combination of encorafenib and binimetinib in this patient population.
There are two arms: medical and surgical. Subjects on the surgical arm must have a high-grade glioma or a known BRAF-mutated low-grade glioma with high clinical suspicion for progression to high-grade.
Medical: Following enrollment, patients will receive encorafenib and binimetinib at the FDA-approved dose of 450 mg of encorafenib once daily and the FDA-approved dose of 45 mg of binimetinib twice daily separated by 12 hours, continuously in 28-day cycles until progression or unacceptable toxicity. Patients will be followed by routine blood work, and general and neurological examination. A brain MRI will be performed prior to every odd-numbered cycle (every 8 weeks). Response will be assessed by RANO criteria. Patients may remain on study and receive treatment until progression or other reason.
Surgical: These subjects will take encorafenib and binimetinib in combination at their FDA-approved doses for 10-14 days prior to surgery. The last dose of both drugs will be administered two hours prior to surgery. Specimens will be collected during surgery. After surgery, the subjects will not take further encorafenib or binimetinib until a study visit to assess their neurological exam, physical exam, and performance status, at 2-6 weeks post-operatively. At time of restarting combination treatment, subjects will follow the schedule for the medical cohort, and will continue treatment until progression.
- Conditions
- High Grade Glioma, BRAF V600E, BRAF V600K, Anaplastic Astrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Gliosarcoma
- Being tested
- Encorafenib, Binimetinib, Research Bloods, Tumor Tissue
- Keywords
- BRAF V600E/K, High Grade Primary Brain Tumor, High Grade Glioma, Glioblastoma
- Medical subject headings
- Glioma, Astrocytoma, Gliosarcoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EncorafenibDrug
Also called Braftovi
450mg QD 28 day cycle
BinimetinibDrug
Also called Mektovi
45mg BID 28 day cycle
Research BloodsBiological
Also called Circulating Tumor DNA
Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor TissueBiological
at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort 1 AA & GBM | Experimental | Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods Receives: Drug: Encorafenib; Drug: Binimetinib; Biological: Research Bloods; Biological: Tumor Tissue |
| Treatment Cohort 2 anaplastic PXAs | Experimental | Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods Receives: Drug: Encorafenib; Drug: Binimetinib; Biological: Research Bloods; Biological: Tumor Tissue |
| Surgical Arm | Experimental | Pre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery
Tumor; research blood; CSF samples
post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Receives: Drug: Encorafenib; Drug: Binimetinib; Biological: Research Bloods; Biological: Tumor Tissue |
| Treatment Cohort 3 Other Tumors | Experimental | Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods Receives: Drug: Encorafenib; Drug: Binimetinib; Biological: Research Bloods; Biological: Tumor Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Number of participants from each treatment cohort with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= <50% reduction to <25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Measured: Up to 1 year
Secondary outcomes (4)
Progression Free Survival for 3 Treatment Cohorts
Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
Measured: up to 3 years
Overall Survival
overall survival in months. Specific survival for each patient due to early termination
Measured: up to 3 years
Duration of Response - Complete and Partial
Time from response to progression. Response is defined by RANO: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= <50% reduction to <25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Measured: up to 3 year
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
time from first dose to 30 days post last dose
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start29 Jul 2019
- Primary completion30 Apr 2022
- Study completion1 Oct 2023
Why it stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Responsible party
- Sponsor
- Investigators
- Karisa C Schreck, MD, Principal investigator, ABTCStuart A Grossman, MD, Study chair, ABTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973918
- Sponsor's protocol ID
- ABTC 1802
- Other IDs
- UM1CA137443
- Acronym
- BRAF
- Status last verified
- Oct 2024
- First submitted
- 31 May 2019
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Binimetinib in Combination With Encorafenib in Adults With Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor
- ClinicalTrials.gov ID
- NCT03973918
- Acronym / sponsor ID
- BRAF / ABTC 1802
- Conditions
- High Grade Glioma, BRAF V600E, BRAF V600K, Anaplastic Astrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Gliosarcoma
- Keywords
- BRAF V600E/K, High Grade Primary Brain Tumor, High Grade Glioma, Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors.
Detailed description
Primary Objective Estimate the efficacy of combination treatment with encorafenib and binimetinib, as measured by response rate (RANO criteria), in patients with recurrent BRAF V600E/K-mutated malignant glioma (MG) and anaplastic pleomorphic xanthoastrocytoma (PXAs).
Secondary Objectives
- Estimate efficacy as measured by progression-free survival in subjects with recurrent malignant glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.
- Evaluate duration of response in subjects who have a partial or complete response.
- Quantify the time-to-response among subjects who have a radiologic response.
- Estimate efficacy as measured by overall survival in subjects with recurrent malignant glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.
- Characterize the toxicity profile of the combination of encorafenib and binimetinib in this patient population.
There are two arms: medical and surgical. Subjects on the surgical arm must have a high-grade glioma or a known BRAF-mutated low-grade glioma with high clinical suspicion for progression to high-grade.
Medical: Following enrollment, patients will receive encorafenib and binimetinib at the FDA-approved dose of 450 mg of encorafenib once daily and the FDA-approved dose of 45 mg of binimetinib twice daily separated by 12 hours, continuously in 28-day cycles until progression or unacceptable toxicity. Patients will be followed by routine blood work, and general and neurological examination. A brain MRI will be performed prior to every odd-numbered cycle (every 8 weeks). Response will be assessed by RANO criteria. Patients may remain on study and receive treatment until progression or other reason.
Surgical: These subjects will take encorafenib and binimetinib in combination at their FDA-approved doses for 10-14 days prior to surgery. The last dose of both drugs will be administered two hours prior to surgery. Specimens will be collected during surgery. After surgery, the subjects will not take further encorafenib or binimetinib until a study visit to assess their neurological exam, physical exam, and performance status, at 2-6 weeks post-operatively. At time of restarting combination treatment, subjects will follow the schedule for the medical cohort, and will continue treatment until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort 1 AA & GBM | Experimental | Drug: Encorafenib, Drug: Binimetinib, Biological: Research Bloods, Biological: Tumor TissueEncorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods |
| Treatment Cohort 2 anaplastic PXAs | Experimental | Drug: Encorafenib, Drug: Binimetinib, Biological: Research Bloods, Biological: Tumor TissueEncorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods |
| Surgical Arm | Experimental | Drug: Encorafenib, Drug: Binimetinib, Biological: Research Bloods, Biological: Tumor TissuePre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery Tumor; research blood; CSF samples post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle |
| Treatment Cohort 3 Other Tumors | Experimental | Drug: Encorafenib, Drug: Binimetinib, Biological: Research Bloods, Biological: Tumor TissueEncorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients receiving any other standard or investigational agents are ineligible.
- Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
- Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by MRI imaging within 30 days of starting treatment.
- The following intervals from previous treatments are required to be eligible:
- Patients must be 18 years of age or older.
Key exclusion criteria (22 listed)
- Patients receiving any other standard or investigational agents are ineligible.
- Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
- Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients
- Current use of a prohibited medication (including herbal medications, supplements, or foods), or use of a prohibited medication ≤ 7 days prior to the start of study treatment.
- Patient has not recovered to ≤ Grade 1 non-hematologic toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EncorafenibAlso: Braftovi450mg QD 28 day cycle | Drug | Surgical Arm, Treatment Cohort 1 AA & GBM, Treatment Cohort 2 anaplastic PXAs, Treatment Cohort 3 Other Tumors |
| BinimetinibAlso: Mektovi45mg BID 28 day cycle | Drug | Surgical Arm, Treatment Cohort 1 AA & GBM, Treatment Cohort 2 anaplastic PXAs, Treatment Cohort 3 Other Tumors |
| Research BloodsAlso: Circulating Tumor DNABaseline; pre-cycle 3; Pre-cycle 7; off Treatment | Biological | Surgical Arm, Treatment Cohort 1 AA & GBM, Treatment Cohort 2 anaplastic PXAs, Treatment Cohort 3 Other Tumors |
| Tumor Tissueat time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides | Biological | Surgical Arm, Treatment Cohort 1 AA & GBM, Treatment Cohort 2 anaplastic PXAs, Treatment Cohort 3 Other Tumors |
Primary outcome
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Time frame: Up to 1 year
Number of participants from each treatment cohort with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= <50% reduction to <25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
4 secondary outcomes
Progression Free Survival for 3 Treatment Cohorts
Time frame: up to 3 years
Overall Survival
Time frame: up to 3 years
Duration of Response - Complete and Partial
Time frame: up to 3 year
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for High Grade Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karisa C Schreck, MD principal investigator
ABTC
Stuart A Grossman, MD study chair
ABTC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encorafenib, Binimetinib and Research Bloods in people with High Grade Glioma and BRAF V600E, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.