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NCT03517449 · OUTCOME

Plasma Concentration of Lenvatinib Versus Time in All-comer Participants

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) · Source last updated 2026-03-19

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

Measure
MEAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 day 1 0.5-4 hours (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)

What was measured

Pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.

Analysis population: Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.

Groups in this outcome

Lenvatinib 20 mg + Pembrolizumab 200 mg

Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

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

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg403

Reported measurements

Cycle 1 Day 1, 0.5-4h Post-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg317
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg152181Not reportedNot reportedNot reported
Cycle 1 Day 1, 6-10 h Post-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg345
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg258124Not reportedNot reportedNot reported
Cycle 1 Day 15, Pre-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg332
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg89.169.6Not reportedNot reportedNot reported
Cycle 1 Day 15, 2-12 h Post-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg316
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg310218Not reportedNot reportedNot reported
Cycle 2 Day 1, Pre-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg300
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg67.274.7Not reportedNot reportedNot reported
Cycle 2 Day 1, 0.5-4h

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg342
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg151155Not reportedNot reportedNot reported
Cycle 2 Day 1, 6-10 h

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg283
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg258138Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        181
        value
        152
    denoms
    1. counts
      1. group Id
        OG000
        value
        317
      units
      Participants
    title
    Cycle 1 Day 1, 0.5-4h Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        124
        value
        258
    denoms
    1. counts
      1. group Id
        OG000
        value
        345
      units
      Participants
    title
    Cycle 1 Day 1, 6-10 h Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.6
        value
        89.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        332
      units
      Participants
    title
    Cycle 1 Day 15, Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        218
        value
        310
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      units
      Participants
    title
    Cycle 1 Day 15, 2-12 h Post-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.7
        value
        67.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        300
      units
      Participants
    title
    Cycle 2 Day 1, Pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        155
        value
        151
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      units
      Participants
    title
    Cycle 2 Day 1, 0.5-4h
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        138
        value
        258
    denoms
    1. counts
      1. group Id
        OG000
        value
        283
      units
      Participants
    title
    Cycle 2 Day 1, 6-10 h
denoms
  1. counts
    1. group Id
      OG000
      value
      403
    units
    Participants
description
Pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
    id
    OG000
    title
    Lenvatinib 20 mg + Pembrolizumab 200 mg
param Type
MEAN
population Description
Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.
reporting Status
POSTED
time Frame
Cycle 1 day 1 0.5-4 hours (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)
title
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice