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NCT04447755 · OUTCOME

Clinical Benefit Rate (CBR) 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 21 months

What was measured

CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ewing Sarcoma33.3Not reported7.570.1Not reported
Rhabdomyosarcoma29.4Not reported10.356.0Not reported
High Grade Glioma0.0Not reported0.045.9Not reported
Diffuse Midline Glioma11.1Not reported0.348.2Not reported
Medulloblastoma44.4Not reported13.778.8Not reported
Ependymoma33.3Not reported7.570.1Not reported
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma40.0Not reported28.052.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.5
        upper Limit
        70.1
        value
        33.3
      2. group Id
        OG001
        lower Limit
        10.3
        upper Limit
        56.0
        value
        29.4
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.3
        upper Limit
        48.2
        value
        11.1
      5. group Id
        OG004
        lower Limit
        13.7
        upper Limit
        78.8
        value
        44.4
      6. group Id
        OG005
        lower Limit
        7.5
        upper Limit
        70.1
        value
        33.3
      7. group Id
        OG006
        lower Limit
        28.0
        upper Limit
        52.9
        value
        40.0
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
CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information.
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
NUMBER
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
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice