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NCT03126110 · OUTCOME

Phase 1: ORR 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
up to approximately 44.7 months

What was measured

ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments 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.

Analysis population: Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment

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 Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W25.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W0.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W20.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W0.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W0.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W0.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W25.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W25.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W12.5Not reportedNot reportedNot reportedNot reported
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W0.0Not reportedNot reportedNot reportedNot reported
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        20.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        25.0
      8. group Id
        OG007
        value
        25.0
      9. group Id
        OG008
        value
        12.5
      10. group Id
        OG009
        value
        0.0
      11. group Id
        OG010
        value
        0.0
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
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments 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.
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
NUMBER
population Description
Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment
reporting Status
POSTED
time Frame
up to approximately 44.7 months
title
Phase 1: ORR Per RECIST v1.1
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice