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NCT03241173 · OUTCOME

Phase 2: Objective Response Rate (ORR)

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies · Source last updated 2022-09-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
up to 24 months

What was measured

ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). 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 of the study did not open for enrollment.

Groups in this outcome

Phase 2, Part A: INCAGN01949 + Nivolumab

Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) were to have received a range of doses of INCAGN01949 found to be safe in Phase 1 in combination with nivolumab, administered as IV infusions

Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab

PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC were to have received a range of doses of INCAGN01949 found to be safe in Phase 1. INCAGN01949 was to have been administered alone, in combination with nivolumab, and in combination with nivolumab and ipilimumab, administered as IV infusions.

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, Part A: INCAGN01949 + Nivolumab0
Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). 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.
groups
  1. description
    Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) were to have received a range of doses of INCAGN01949 found to be safe in Phase 1 in combination with nivolumab, administered as IV infusions
    id
    OG000
    title
    Phase 2, Part A: INCAGN01949 + Nivolumab
  2. description
    PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC were to have received a range of doses of INCAGN01949 found to be safe in Phase 1. INCAGN01949 was to have been administered alone, in combination with nivolumab, and in combination with nivolumab and ipilimumab, administered as IV infusions.
    id
    OG001
    title
    Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab
population Description
Phase 2 of the study did not open for enrollment.
reporting Status
POSTED
time Frame
up to 24 months
title
Phase 2: Objective Response Rate (ORR)
type
PRIMARY

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

Preserved source evidence · Not medical advice