Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03905135 · OUTCOME

Mean Duration of Response (DOR)

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies · Source last updated 2022-09-13

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

Measure
MEAN
Unit
Days
Interval / dispersion
Standard Deviation
Time frame
From the time that response to therapy is first documented until progressive disease is observed or the subject is lost to follow-up or approximately 2 years.

What was measured

DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), death, or, in the absence of progressive disease (PD), date of last assessment. The response rate was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.

Groups in this outcome

Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab

Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.

Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab

Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab6
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab2

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab107115Not reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg AvelumabNANANot reportedNot reportedCannot report because none in dose level 2 had a partial response or complete response.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        115
        value
        107
      2. comment
        Cannot report because none in dose level 2 had a partial response or complete response.
        group Id
        OG001
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    units
    Participants
description
DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), death, or, in the absence of progressive disease (PD), date of last assessment. The response rate was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.
dispersion Type
Standard Deviation
groups
  1. description
    Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
    id
    OG000
    title
    Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
  2. description
    Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
    id
    OG001
    title
    Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
param Type
MEAN
reporting Status
POSTED
time Frame
From the time that response to therapy is first documented until progressive disease is observed or the subject is lost to follow-up or approximately 2 years.
title
Mean Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice