NCT03126110 · OUTCOME

Phase 2: Objective Response Rate (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 confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (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 millimeters (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 2 Response Evaluable Population: all participants enrolled in Phase 2 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 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

Group	Source count
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg	8
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg	16
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg	46
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg	18
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg	4
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg	2

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg	0.0	Not reported	Not reported	Not reported	Not reported
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg	0.0	Not reported	Not reported	Not reported	Not reported
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg	23.9	Not reported	Not reported	Not reported	Not reported
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg	16.7	Not reported	Not reported	Not reported	Not reported
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg	0.0	Not reported	Not reported	Not reported	Not reported
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg	0.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.0
group Id
OG002
value
23.9
group Id
OG003
value
16.7
group Id
OG004
value
0.0
group Id
OG005
value
0.0

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
46
group Id
OG003
value
18
group Id
OG004
value
4
group Id
OG005
value
2
units
Participants

description

groups

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
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
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
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
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
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

NUMBER

population Description

Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 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 2: Objective Response Rate (ORR) Per RECIST v1.1

type

PRIMARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice