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NCT02857426 · OUTCOME

Overall Survival (OS)

A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) · Source last updated 2021-12-23

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 51 months

What was measured

Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations. OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.

Analysis population: All treated PCNSL and PTL participants

Groups in this outcome

PCNSL Cohort

Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.

PTL Cohort

Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.

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

Analysis denominator · Participants

GroupSource count
PCNSL Cohort47
PTL Cohort19

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PCNSL Cohort6.77Not reported3.6811.99Not reported
PTL Cohort11.17Not reported2.6024.41Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.68
        upper Limit
        11.99
        value
        6.77
      2. group Id
        OG001
        lower Limit
        2.60
        upper Limit
        24.41
        value
        11.17
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations. OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
    id
    OG000
    title
    PCNSL Cohort
  2. description
    Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
    id
    OG001
    title
    PTL Cohort
param Type
MEDIAN
population Description
All treated PCNSL and PTL participants
reporting Status
POSTED
time Frame
Up to approximately 51 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice