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NCT04730349 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) - Part A

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer · Source last updated 2023-03-24

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
From first dose to 30 days after last dose (up to approximately 6 months)

What was measured

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Analysis population: Data was not and will never be collected

Groups in this outcome

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)

Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)

Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks

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

Analysis denominator · Participants

GroupSource count
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)0
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)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
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
groups
  1. description
    Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
    id
    OG000
    title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
  2. description
    Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
    id
    OG001
    title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
population Description
Data was not and will never be collected
reporting Status
POSTED
time Frame
From first dose to 30 days after last dose (up to approximately 6 months)
title
Maximum Observed Plasma Concentration (Cmax) - Part A
type
PRIMARY

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

Preserved source evidence · Not medical advice