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NCT03126110 · OUTCOME

Phase 2: 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
MEDIAN
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 2 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 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg

Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg

Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

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 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg3
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg9
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg26
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg10
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg2
Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg1

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg218.0Not reported133.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg168.0Not reported63.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mgNANot reported202.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mgNANot reported137.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mgNANot reported118.0NAThe median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mgNANot reportedNANAThe median and the upper and lower limits 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
        133.0
        upper Limit
        NA
        value
        218.0
      2. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG001
        lower Limit
        63.0
        upper Limit
        NA
        value
        168.0
      3. 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
        OG002
        lower Limit
        202.0
        upper Limit
        NA
        value
        NA
      4. 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
        OG003
        lower Limit
        137.0
        upper Limit
        NA
        value
        NA
      5. 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
        OG004
        lower Limit
        118.0
        upper Limit
        NA
        value
        NA
      6. 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
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      1
    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 with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    OG000
    title
    Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
  2. description
    Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG001
    title
    Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
  3. description
    Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG002
    title
    Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
  4. description
    Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG003
    title
    Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
  5. description
    Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG004
    title
    Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
  6. description
    Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    OG005
    title
    Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
param Type
MEDIAN
population Description
Phase 2 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 2: 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