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NCT03126110 · OUTCOME

Phase 1: PFS Per mRECIST v1.1

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies · Source last updated 2025-08-14

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
up to approximately 44.7 months

What was measured

According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).

Analysis population: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

Groups in this outcome

Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.

Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

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

Analysis denominator · Participants

GroupSource count
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W4
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W4
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W5
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W4
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W5
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W4
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W4
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W4
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W8
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W3
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab6

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W66.0Not reported48.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WNANot reported55.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W116.0Not reported64.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W88.0Not reported76.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W57.0Not reported29.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WNANot reported100.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W98.0Not reported52.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WNANot reported97.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W134.0Not reported53.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W128.0Not reported56.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 1 Group D: INCAGN01876 + Nivolumab + IpilimumabNANot reported46.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG000
        lower Limit
        48.0
        upper Limit
        NA
        value
        66.0
      2. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG001
        lower Limit
        55.0
        upper Limit
        NA
        value
        NA
      3. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG002
        lower Limit
        64.0
        upper Limit
        NA
        value
        116.0
      4. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG003
        lower Limit
        76.0
        upper Limit
        NA
        value
        88.0
      5. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG004
        lower Limit
        29.0
        upper Limit
        NA
        value
        57.0
      6. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG005
        lower Limit
        100.0
        upper Limit
        NA
        value
        NA
      7. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG006
        lower Limit
        52.0
        upper Limit
        NA
        value
        98.0
      8. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG007
        lower Limit
        97.0
        upper Limit
        NA
        value
        NA
      9. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG008
        lower Limit
        53.0
        upper Limit
        NA
        value
        134.0
      10. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG009
        lower Limit
        56.0
        upper Limit
        NA
        value
        128.0
      11. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG010
        lower Limit
        46.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      8
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      6
    units
    Participants
description
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
    id
    OG000
    title
    Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  2. description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG001
    title
    Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  3. description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG002
    title
    Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  4. description
    Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG003
    title
    Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  5. description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    OG004
    title
    Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  6. description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    OG005
    title
    Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  7. description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    OG006
    title
    Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  8. description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
    id
    OG007
    title
    Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  9. description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    OG008
    title
    Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  10. description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    OG009
    title
    Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  11. description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
    id
    OG010
    title
    Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
param Type
MEDIAN
population Description
Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
reporting Status
POSTED
time Frame
up to approximately 44.7 months
title
Phase 1: PFS Per mRECIST v1.1
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice