Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05070247 · OUTCOME

Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors · Source last updated 2026-01-22

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

Measure
MEAN
Unit
cells per square millimeter (cells/mm^2)
Interval / dispersion
Standard Deviation
Time frame
Up to 23 days after first administration of TAK-500

What was measured

Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.

Analysis population: The tumor biopsy analysis set included participants from the safety population who had baseline and at least 1 postbaseline tumor biopsy sample assessments.

Groups in this outcome

Single Agent Dose Escalation: TAK-500 8 µg/kg

Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.

Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Single Agent Dose Escalation: TAK-500 16 µg/kg

Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg

Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.

Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.

Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

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

Analysis denominator · Participants

GroupSource count
Single Agent Dose Escalation: TAK-500 8 µg/kg0
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg0
Single Agent Dose Escalation: TAK-500 16 µg/kg2
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg2
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg3
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg2
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg0
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg0
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg1
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg0
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg2
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg0
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg3
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg1

Reported measurements

Source class 1
Values in cells per square millimeter (cells/mm^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Single Agent Dose Escalation: TAK-500 16 µg/kg1.150.919239Not reportedNot reportedNot reported
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg0.650.636396Not reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg3.234.389001Not reportedNot reportedNot reported
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg0.750.777817Not reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg1.40NANot reportedNot reportedSD was not estimable for a single participant.
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg3.403.959798Not reportedNot reportedNot reported
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg3.004.246175Not reportedNot reportedNot reported
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg0.70NANot reportedNot reportedSD was not estimable for a single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG002
        spread
        0.919239
        value
        1.15
      2. group Id
        OG003
        spread
        0.636396
        value
        0.65
      3. group Id
        OG004
        spread
        4.389001
        value
        3.23
      4. group Id
        OG005
        spread
        0.777817
        value
        0.75
      5. comment
        SD was not estimable for a single participant.
        group Id
        OG008
        spread
        NA
        value
        1.40
      6. group Id
        OG010
        spread
        3.959798
        value
        3.40
      7. group Id
        OG012
        spread
        4.246175
        value
        3.00
      8. comment
        SD was not estimable for a single participant.
        group Id
        OG013
        spread
        NA
        value
        0.70
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      1
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      2
    12. group Id
      OG011
      value
      0
    units
    Participants
description
Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
    id
    OG000
    title
    Single Agent Dose Escalation: TAK-500 8 µg/kg
  2. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    OG001
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
  3. description
    Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    OG002
    title
    Single Agent Dose Escalation: TAK-500 16 µg/kg
  4. description
    Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    OG003
    title
    Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
  5. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    OG004
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
  6. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    OG005
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
  7. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    OG006
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
  8. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    OG007
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
  9. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    OG008
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
  10. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    OG009
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
  11. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    OG010
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
  12. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    OG011
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
param Type
MEAN
population Description
The tumor biopsy analysis set included participants from the safety population who had baseline and at least 1 postbaseline tumor biopsy sample assessments.
reporting Status
POSTED
time Frame
Up to 23 days after first administration of TAK-500
title
Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration
type
SECONDARY
unit Of Measure
cells per square millimeter (cells/mm^2)

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

Preserved source evidence · Not medical advice