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NCT04447755 · OUTCOME

Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) · Source last updated 2025-10-03

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 21 months

What was measured

PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).

Analysis population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

Groups in this outcome

Ewing Sarcoma

Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.

Rhabdomyosarcoma

Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

High Grade Glioma

Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Diffuse Midline Glioma

Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Medulloblastoma

Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Ependymoma

Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma

Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Ewing Sarcoma9
Rhabdomyosarcoma17
High Grade Glioma6
Diffuse Midline Glioma9
Medulloblastoma9
Ependymoma9
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma65

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ewing Sarcoma3.0Not reported0.39.3Not reported
Rhabdomyosarcoma2.6Not reported1.25.6Not reported
High Grade Glioma1.9Not reported1.4NANA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Diffuse Midline Glioma1.8Not reported0.54.9Not reported
Medulloblastoma3.4Not reported0.58.5Not reported
Ependymoma2.5Not reported1.27.4Not reported
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma3.8Not reported3.25.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        9.3
        value
        3.0
      2. group Id
        OG001
        lower Limit
        1.2
        upper Limit
        5.6
        value
        2.6
      3. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG002
        lower Limit
        1.4
        upper Limit
        NA
        value
        1.9
      4. group Id
        OG003
        lower Limit
        0.5
        upper Limit
        4.9
        value
        1.8
      5. group Id
        OG004
        lower Limit
        0.5
        upper Limit
        8.5
        value
        3.4
      6. group Id
        OG005
        lower Limit
        1.2
        upper Limit
        7.4
        value
        2.5
      7. group Id
        OG006
        lower Limit
        3.2
        upper Limit
        5.7
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      65
    units
    Participants
description
PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
    id
    OG000
    title
    Ewing Sarcoma
  2. description
    Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG001
    title
    Rhabdomyosarcoma
  3. description
    Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG002
    title
    High Grade Glioma
  4. description
    Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG003
    title
    Diffuse Midline Glioma
  5. description
    Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG004
    title
    Medulloblastoma
  6. description
    Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG005
    title
    Ependymoma
  7. description
    Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG006
    title
    Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
param Type
MEDIAN
population Description
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
reporting Status
POSTED
time Frame
Up to approximately 21 months
title
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice