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NCT05949632 · OUTCOME

Part 1: Objective Response

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Source last updated 2026-06-04

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 335 days

What was measured

Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Analysis population: Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method.

Groups in this outcome

INCB099280 400 mg BID Plus Axitinib 5 mg BID

Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.

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

Analysis denominator · Participants

GroupSource count
INCB099280 400 mg BID Plus Axitinib 5 mg BID5

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID20.0Not reported0.571.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        71.6
        value
        20.0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
    id
    OG000
    title
    INCB099280 400 mg BID Plus Axitinib 5 mg BID
param Type
NUMBER
population Description
Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method.
reporting Status
POSTED
time Frame
up to 335 days
title
Part 1: Objective Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice