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NCT02428192 · OUTCOME

PDL1 Status

Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma · Source last updated 2025-02-25

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 100 days

What was measured

The relationship between PDL1 status and response to nivolumab will be explored. A Fisher's exact test will be used to assess the relationship between each biomarker and response to treatment. The power to detect the relationship of interest increases as the prevalence of the biomarker increases.

Analysis population: to few responders to analyze biomarker data

Groups in this outcome

Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)

Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV

Cohort B (Nivolumab and Ipilimumab)

Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)0
Cohort B (Nivolumab and Ipilimumab)0

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
The relationship between PDL1 status and response to nivolumab will be explored. A Fisher's exact test will be used to assess the relationship between each biomarker and response to treatment. The power to detect the relationship of interest increases as the prevalence of the biomarker increases.
groups
  1. description
    Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
    id
    OG000
    title
    Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)
  2. description
    Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Cohort B (Nivolumab and Ipilimumab)
population Description
to few responders to analyze biomarker data
reporting Status
POSTED
time Frame
Up to 100 days
title
PDL1 Status
type
SECONDARY

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

Preserved source evidence · Not medical advice