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NCT03126110 · OUTCOME

Phase 2: Duration of Disease Control Per RECIST 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. 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 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. 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 mg25
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 reported106.0NAThe 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 mg109.0Not 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 mg253.0Not reported156.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg168.0Not reported71.0NAThe upper limit of the confidence interval was 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 mg206.5Not reported118.0NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg109.0Not reportedNANAThe 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
        106.0
        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
        109.0
      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
        156.0
        upper Limit
        NA
        value
        253.0
      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
        71.0
        upper Limit
        NA
        value
        168.0
      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
        118.0
        upper Limit
        NA
        value
        206.5
      6. comment
        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
        109.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      25
    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. 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 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. 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 RECIST v1.1
type
SECONDARY
unit Of Measure
Days

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