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NCT03126110 · OUTCOME

Phase 2: 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 2 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 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/kg8
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg16
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg46
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg18
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg4
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg2

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/kg85.0Not reported20.0218.0Not reported
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg105.0Not 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 mg235.0Not reported129.0NAThe 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 reported51.0NAThe 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 mg118.0Not reported52.0NAThe 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 mgNANot reported20.0NAThe 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. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        218.0
        value
        85.0
      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
        105.0
      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
        129.0
        upper Limit
        NA
        value
        235.0
      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
        51.0
        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
        52.0
        upper Limit
        NA
        value
        118.0
      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
        20.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      46
    4. group Id
      OG003
      value
      18
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      2
    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 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 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 2: 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