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NCT03797326 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 66 months

What was measured

OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.

Analysis population: All allocated participants who received at least 1 dose of study intervention.

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 D2: Colorectal Cancer (Lenva)

Participants received Lenva 24 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.

Cohort G: Pancreatic 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)31
Cohort B: Ovarian Cancer (Lenva + Pembro)31
Cohort C: Gastric Cancer (Lenva + Pembro)99
Cohort D1: Colorectal Cancer (Lenva + Pembro)105
Cohort D2: Colorectal Cancer (Lenva)30
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)101
Cohort F: Biliary Tract Cancer (Lenva + Pembro)102
Cohort G: Pancreatic Cancer (Lenva + Pembro)103

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)11.4Not reported4.121.7Not reported
Cohort B: Ovarian Cancer (Lenva + Pembro)21.3Not reported11.732.3Not reported
Cohort C: Gastric Cancer (Lenva + Pembro)4.7Not reported3.86.1Not reported
Cohort D1: Colorectal Cancer (Lenva + Pembro)8.7Not reported7.010.0Not reported
Cohort D2: Colorectal Cancer (Lenva)7.9Not reported5.614.9Not reported
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)8.6Not reported7.410.8Not reported
Cohort F: Biliary Tract Cancer (Lenva + Pembro)7.9Not reported5.69.5Not reported
Cohort G: Pancreatic Cancer (Lenva + Pembro)4.3Not reported3.85.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        21.7
        value
        11.4
      2. group Id
        OG001
        lower Limit
        11.7
        upper Limit
        32.3
        value
        21.3
      3. group Id
        OG002
        lower Limit
        3.8
        upper Limit
        6.1
        value
        4.7
      4. group Id
        OG003
        lower Limit
        7.0
        upper Limit
        10.0
        value
        8.7
      5. group Id
        OG004
        lower Limit
        5.6
        upper Limit
        14.9
        value
        7.9
      6. group Id
        OG005
        lower Limit
        7.4
        upper Limit
        10.8
        value
        8.6
      7. group Id
        OG006
        lower Limit
        5.6
        upper Limit
        9.5
        value
        7.9
      8. group Id
        OG007
        lower Limit
        3.8
        upper Limit
        5.4
        value
        4.3
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      31
    3. group Id
      OG002
      value
      99
    4. group Id
      OG003
      value
      105
    5. group Id
      OG004
      value
      30
    6. group Id
      OG005
      value
      101
    7. group Id
      OG006
      value
      102
    8. group Id
      OG007
      value
      103
    units
    Participants
description
OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.
dispersion Type
95% Confidence Interval
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 Lenva 24 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 D2: Colorectal Cancer (Lenva)
  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 E: Glioblastoma Multiforma (Lenva + Pembro)
  7. 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
    OG006
    title
    Cohort F: Biliary Tract Cancer (Lenva + Pembro)
  8. 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
    OG007
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
param Type
MEDIAN
population Description
All allocated participants who received at least 1 dose of study intervention.
reporting Status
POSTED
time Frame
Up to approximately 66 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice