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NCT03797326 · OUTCOME

Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) · Source last updated 2026-05-04

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

Measure
MEAN
Unit
ng*hr/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.

What was measured

Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.

Analysis population: All allocated participants who received at least 1 dose of study intervention and had data available for this endpoint.

Groups in this outcome

Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)

Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

Cohort B: Ovarian Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

Cohort C: Gastric Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

Cohort D1: Colorectal Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

Cohort E: Glioblastoma Multiforma (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

Cohort F: Biliary Tract Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention 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
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)30
Cohort B: Ovarian Cancer (Lenva + Pembro)31
Cohort C: Gastric Cancer (Lenva + Pembro)93
Cohort D1: Colorectal Cancer (Lenva + Pembro)104
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)100
Cohort F: Biliary Tract Cancer (Lenva + Pembro)100

Reported measurements

Source class 1
Values in ng*hr/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)32531029Not reportedNot reportedNot reported
Cohort B: Ovarian Cancer (Lenva + Pembro)3145984Not reportedNot reportedNot reported
Cohort C: Gastric Cancer (Lenva + Pembro)2392803Not reportedNot reportedNot reported
Cohort D1: Colorectal Cancer (Lenva + Pembro)29941143Not reportedNot reportedNot reported
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)2617804Not reportedNot reportedNot reported
Cohort F: Biliary Tract Cancer (Lenva + Pembro)2886838Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1029
        value
        3253
      2. group Id
        OG001
        spread
        984
        value
        3145
      3. group Id
        OG002
        spread
        803
        value
        2392
      4. group Id
        OG003
        spread
        1143
        value
        2994
      5. group Id
        OG004
        spread
        804
        value
        2617
      6. group Id
        OG005
        spread
        838
        value
        2886
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      31
    3. group Id
      OG002
      value
      93
    4. group Id
      OG003
      value
      104
    5. group Id
      OG004
      value
      100
    6. group Id
      OG005
      value
      100
    units
    Participants
description
Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG000
    title
    Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
  2. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG001
    title
    Cohort B: Ovarian Cancer (Lenva + Pembro)
  3. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG002
    title
    Cohort C: Gastric Cancer (Lenva + Pembro)
  4. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG003
    title
    Cohort D1: Colorectal Cancer (Lenva + Pembro)
  5. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG004
    title
    Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
  6. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    OG005
    title
    Cohort F: Biliary Tract Cancer (Lenva + Pembro)
param Type
MEAN
population Description
All allocated participants who received at least 1 dose of study intervention and had data available for this endpoint.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.
title
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib
type
SECONDARY
unit Of Measure
ng*hr/mL

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Preserved source evidence · Not medical advice