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NCT03797326 · OUTCOME

Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 66 months

What was measured

DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] 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. The DCR as assessed by BICR is presented.

Analysis population: All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

Groups in this outcome

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 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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort C: Gastric Cancer (Lenva + Pembro)53.5Not reported43.263.6Not reported
Cohort D1: Colorectal Cancer (Lenva + Pembro)52.4Not reported42.462.2Not reported
Cohort D2: Colorectal Cancer (Lenva)56.7Not reported37.474.5Not reported
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)57.4Not reported47.267.2Not reported
Cohort F: Biliary Tract Cancer (Lenva + Pembro)64.7Not reported54.673.9Not reported
Cohort G: Pancreatic Cancer (Lenva + Pembro)37.9Not reported28.548.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.2
        upper Limit
        63.6
        value
        53.5
      2. group Id
        OG001
        lower Limit
        42.4
        upper Limit
        62.2
        value
        52.4
      3. group Id
        OG002
        lower Limit
        37.4
        upper Limit
        74.5
        value
        56.7
      4. group Id
        OG003
        lower Limit
        47.2
        upper Limit
        67.2
        value
        57.4
      5. group Id
        OG004
        lower Limit
        54.6
        upper Limit
        73.9
        value
        64.7
      6. group Id
        OG005
        lower Limit
        28.5
        upper Limit
        48.0
        value
        37.9
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      105
    3. group Id
      OG002
      value
      30
    4. group Id
      OG003
      value
      101
    5. group Id
      OG004
      value
      102
    6. group Id
      OG005
      value
      103
    units
    Participants
description
DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] 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. The DCR as assessed by BICR is presented.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Cohort C: Gastric 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 D1: Colorectal Cancer (Lenva + Pembro)
  3. 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
    OG002
    title
    Cohort D2: Colorectal Cancer (Lenva)
  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 E: Glioblastoma Multiforma (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 F: Biliary Tract Cancer (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 G: Pancreatic Cancer (Lenva + Pembro)
param Type
NUMBER
population Description
All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
reporting Status
POSTED
time Frame
Up to approximately 66 months
title
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice