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NCT03126110 · OUTCOME

Phase 1: Duration of Disease Control 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
MEAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
up to approximately 44.7 months

What was measured

Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. 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). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Analysis population: Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.

Groups in this outcome

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

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

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 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

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 Q2W1
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W2
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W1
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W2
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W0
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W1
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W2
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W1
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W4
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W0
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg0

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 Q2WNANot reportedNANAThe median and the upper and lower limits of the confidence interval were 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 reportedNANAThe median and the upper and lower limits 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 Q2WNANot reportedNANAThe median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W76.0Not reportedNANAThe upper and lower limits of the confidence interval were 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 reportedNANAThe median and the upper and lower limits 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 Q2W668.5Not reported125.0NAThe 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 reportedNANAThe median and the upper and lower limits 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 Q6WNANot reported134.0NAThe 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 median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        76.0
      5. comment
        The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. 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
        125.0
        upper Limit
        NA
        value
        668.5
      7. comment
        The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      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
        OG008
        lower Limit
        134.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      4
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      0
    units
    Participants
description
Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. 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). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    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 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
param Type
MEAN
population Description
Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
reporting Status
POSTED
time Frame
up to approximately 44.7 months
title
Phase 1: Duration of Disease Control Per mRECIST v1.1
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice