TriangleNCT03973918 · STUDY IN CONTEXT
Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
overall survival in months. Specific survival for each patient due to early termination
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.
time from first dose to 30 days post last dose
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- trial label
- Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0000
- source section id
- NCT03973918-om-0000
- source outcome index
- 0
- endpoint
- Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
- endpoint definition
- 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.
- time origin
- Up to 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0001
- source section id
- NCT03973918-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival for 3 Treatment Cohorts
- endpoint definition
- Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
- time origin
- up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Each row represents a specific patient. the number in that row equals the progression free survival for a specific patient, as there were only 5 patients Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0002
- source section id
- NCT03973918-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- overall survival in months. Specific survival for each patient due to early termination
- time origin
- up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers Each row represents a specific patient. the number in that row equals the overall survival for a specific patient, as there were only 5 patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0003
- source section id
- NCT03973918-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response - Complete and Partial
- endpoint definition
- 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.
- time origin
- up to 3 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Each row represents the type of response. The number in that row equals the duration of response in months (mean) for all patients in cohort who had a response of the row title. There were 5 patients and only 3 patients had a response of CR or PR
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0004
- source section id
- NCT03973918-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
- endpoint definition
- time from first dose to 30 days post last dose
- time origin
- up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment Cohort 1 AA & GBM
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Treatment Cohort 2 Anaplastic PXAs
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Treatment Cohort 3 Other Tumors
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment Cohort 1 AA & GBM
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Treatment Cohort 2 Anaplastic PXAs
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Treatment Cohort 3 Other Tumors
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment Cohort 1 AA & GBM
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Treatment Cohort 2 Anaplastic PXAs
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Treatment Cohort 3 Other Tumors
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment Cohort 1 AA & GBM
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Treatment Cohort 2 Anaplastic PXAs
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Treatment Cohort 3 Other Tumors
- regimen
- Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03973918-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gliosarcoma
- nct id
- NCT03973918
- harm key
- EG000
- source section id
- NCT03973918-ae
- event group key
- EG000
- event group label
- Patients Treated With Encorafenib or Binimetinib in All Cohorts
- serious affected
- 2
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 0
- collection period
- Up to 3 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice