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NCT02657889 · OUTCOME

Phase 2: Duration of Response (DOR) as Measured by RECIST v1.1

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer · Source last updated 2022-12-01

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Up to a maximum of 54 months

What was measured

DoR per RECIST v1.1 was defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.

Analysis population: Full Analysis Set. Only those participants with data available at specified time point were analyzed.

Groups in this outcome

Phase 2 OC: Niraparib 200 mg + Pembrolizumab

Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab

Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

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 OC: Niraparib 200 mg + Pembrolizumab8
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab14.4Not reported8.318.7Not reported
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab21.5Not reported8.4NA\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        18.7
        value
        14.4
      2. comment
        \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
        group Id
        OG001
        lower Limit
        8.4
        upper Limit
        NA
        value
        21.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      10
    units
    Participants
description
DoR per RECIST v1.1 was defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Phase 2 OC: Niraparib 200 mg + Pembrolizumab
  2. description
    Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG001
    title
    Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
param Type
MEDIAN
population Description
Full Analysis Set. Only those participants with data available at specified time point were analyzed.
reporting Status
POSTED
time Frame
Up to a maximum of 54 months
title
Phase 2: Duration of Response (DOR) as Measured by RECIST v1.1
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice