NCT03905135 · OUTCOME

Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells

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: From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years

What was measured

Response 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. 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.

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

Group	Source count
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab	6
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab	2

Reported measurements

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab	2	Not reported	Not reported	Not reported	Not reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab	0	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab	2	Not reported	Not reported	Not reported	Not reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab	2	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab	2	Not reported	Not reported	Not reported	Not reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab	0	Not reported	Not reported	Not reported	Not reported

Minor Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab	0	Not reported	Not reported	Not reported	Not reported
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Partial Response
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Progressive Disease
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Stable Disease
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Minor Response

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
2
units
Participants

description

groups

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
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

From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years

title

Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice