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NCT03517449 · OUTCOME

Plasma Concentration of Lenvatinib Versus Time in pMMR 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
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 day 1 0.5-4 hour (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

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. Data is reported for pMMR participants. 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 mg63

Reported measurements

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

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg50
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg140180Not reportedNot reportedNot reported
Cycle 1 Day 1, 6-10 h Post-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg51
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg283136Not reportedNot reportedNot reported
Cycle 1 Day 15, Pre-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg51
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg93.861.4Not reportedNot reportedNot reported
Cycle 1 Day 15, 2-12 h Post-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg51
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg335256Not reportedNot reportedNot reported
Cycle 2 Day 1, Pre-dose

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg44
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg67.960.9Not reportedNot reportedNot reported
Cycle 2 Day 1, 0.5-4 h

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg58
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg153127Not reportedNot reportedNot reported
Cycle 2 Day 1, 6-10 h

Analysis denominator · Participants

GroupSource count
Lenvatinib 20 mg + Pembrolizumab 200 mg41
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib 20 mg + Pembrolizumab 200 mg278132Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        180
        value
        140
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 1 Day 1, 0.5-4 h Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        136
        value
        283
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 Day 1, 6-10 h Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.4
        value
        93.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 Day 15, Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        256
        value
        335
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 Day 15, 2-12 h Post-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.9
        value
        67.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Cycle 2 Day 1, Pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        127
        value
        153
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Cycle 2 Day 1, 0.5-4 h
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        132
        value
        278
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Cycle 2 Day 1, 6-10 h
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
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. Data is reported for pMMR participants. 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 hour (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 pMMR Participants
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice