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NCT03973918 · OUTCOME

Tumor Radiographic Response Per RANO for 3 Treatment Cohorts

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG · Source last updated 2024-10-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

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.

Analysis population: Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers

Groups in this outcome

Treatment Cohort 1 AA & GBM

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

Treatment Cohort 2 Anaplastic PXAs

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

Treatment Cohort 3 Other Tumors

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM2
Treatment Cohort 2 Anaplastic PXAs2
Treatment Cohort 3 Other Tumors1

Reported measurements

Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM0Not reportedNot reportedNot reportedNot reported
Treatment Cohort 2 Anaplastic PXAs1Not reportedNot reportedNot reportedNot reported
Treatment Cohort 3 Other Tumors0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM2Not reportedNot reportedNot reportedNot reported
Treatment Cohort 2 Anaplastic PXAs0Not reportedNot reportedNot reportedNot reported
Treatment Cohort 3 Other Tumors0Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM0Not reportedNot reportedNot reportedNot reported
Treatment Cohort 2 Anaplastic PXAs0Not reportedNot reportedNot reportedNot reported
Treatment Cohort 3 Other Tumors1Not reportedNot reportedNot reportedNot reported
Progression Disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM0Not reportedNot reportedNot reportedNot reported
Treatment Cohort 2 Anaplastic PXAs1Not reportedNot reportedNot reportedNot reported
Treatment Cohort 3 Other Tumors0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Progression Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    units
    Participants
description
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.
groups
  1. description
    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
    id
    OG000
    title
    Treatment Cohort 1 AA & GBM
  2. description
    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
    id
    OG001
    title
    Treatment Cohort 2 Anaplastic PXAs
  3. description
    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
    id
    OG002
    title
    Treatment Cohort 3 Other Tumors
param Type
COUNT_OF_PARTICIPANTS
population Description
Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
reporting Status
POSTED
time Frame
Up to 1 year
title
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice