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NCT03905135 · OUTCOME

Mean Progression Free Survival (PFS)

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 study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.

What was measured

PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.

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 Avelumab303242Not reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab61.555.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        242
        value
        303
      2. group Id
        OG001
        spread
        55.9
        value
        61.5
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    units
    Participants
description
PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
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 study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
title
Mean Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice