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NCT02657889 · OUTCOME

Phase 2: Disease Control Rate (DCR) 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to 40 weeks

What was measured

DCR is defined as the percentage of participants who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the investigator.

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

Groups in this outcome

Phase 2 OC: Niraparib 200mg + 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 200mg + 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 200mg + Pembrolizumab53
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab55

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200mg + Pembrolizumab58.5Not reported46.370.0Not reported
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab41.8Not reported30.553.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.3
        upper Limit
        70.0
        value
        58.5
      2. group Id
        OG001
        lower Limit
        30.5
        upper Limit
        53.8
        value
        41.8
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      55
    units
    Participants
description
DCR is defined as the percentage of participants who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the investigator.
dispersion Type
90% Confidence Interval
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 200mg + 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 200mg + Pembrolizumab
param Type
NUMBER
population Description
Full Analysis Set. Only those participants with data available at specified time points were analyzed.
reporting Status
POSTED
time Frame
Up to 40 weeks
title
Phase 2: Disease Control Rate (DCR) as Measured by RECIST v1.1
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice