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NCT03241173 · OUTCOME

Phase 1: Duration of Response (DOR)

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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
up to 11.0 months

What was measured

DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or first assessment of PD, 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. PD: progression of a target or non-target lesion or presence of a new lesion.

Analysis population: FAS. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with a confirmed CR or PR were analyzed.

Groups in this outcome

Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.

Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, 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 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg1
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg1
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg0
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg0
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg0
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg0
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg0
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg0
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg0
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg1
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg0

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg97.0Not reportedNANAThe upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mgNANot reportedNANAThe median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg86.0Not 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 and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        97.0
      2. comment
        The median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
        group Id
        OG009
        lower Limit
        NA
        upper Limit
        NA
        value
        86.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      1
    11. group Id
      OG010
      value
      0
    units
    Participants
description
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or first assessment of PD, 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. PD: progression of a target or non-target lesion or presence of a new lesion.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
    id
    OG000
    title
    Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
  2. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG001
    title
    Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
  3. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG002
    title
    Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
  4. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG003
    title
    Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
  5. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG004
    title
    Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
  6. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG005
    title
    Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
  7. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG006
    title
    Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
  8. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    OG007
    title
    Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
  9. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    OG008
    title
    Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
  10. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    OG009
    title
    Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
  11. description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    OG010
    title
    Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
param Type
MEDIAN
population Description
FAS. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with a confirmed CR or PR were analyzed.
reporting Status
POSTED
time Frame
up to 11.0 months
title
Phase 1: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice