NCT02554812 · OUTCOME

Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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: Baseline up to Cycle 2 (up to 8 weeks)

What was measured

Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

Analysis population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.

Groups in this outcome

Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab

During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab

During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab

During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

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
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab	29
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab	28
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab	29

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab	Not reported	Not reported	Not reported	Not reported
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab	Not reported	Not reported	Not reported	Not reported
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
29
group Id
OG001
value
28
group Id
OG002
value
29
units
Participants

description

groups

description
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
id
OG000
title
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
description
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
OG001
title
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
description
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
OG002
title
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab

param Type

COUNT_OF_PARTICIPANTS

population Description

The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Baseline up to Cycle 2 (up to 8 weeks)

title

Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice