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NCT03905135 · OUTCOME

Number of Participants With Overall Best Response

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 cycles (each cycle is 28 days) - approximately 168 days

What was measured

OR is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). 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. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. 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

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab2Not reportedNot reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Minor Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab2Not reportedNot reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab0Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab2Not reportedNot reportedNot reportedNot reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Minor Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Stable Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    units
    Participants
description
OR is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). 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. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. 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
  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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6 cycles (each cycle is 28 days) - approximately 168 days
title
Number of Participants With Overall Best Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice