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NCT03848845 · OUTCOME

Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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 (Day 1) and up to 31 months

What was measured

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.

Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 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
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Reported measurements

Calcium, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	2	Not reported	Not reported	Not reported	Not reported

Calcium, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported

Calcium, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

Carbon dioxide, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

Carbon dioxide, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	3	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported

Carbon dioxide, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

Chloride, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	2	Not reported	Not reported	Not reported	Not reported

Chloride, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported

Chloride, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

Direct bilirubin, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

Direct bilirubin, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	5	Not reported	Not reported	Not reported	Not reported

Direct bilirubin, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

Protein, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	3	Not reported	Not reported	Not reported	Not reported

Protein, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	3	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported

Protein, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

TSH, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

TSH, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	3	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	4	Not reported	Not reported	Not reported	Not reported

TSH, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	3	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	2	Not reported	Not reported	Not reported	Not reported

T4, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

T4, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	5	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6	Not reported	Not reported	Not reported	Not reported

T4, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

T3, Decrease to Low

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported

T3, Change to Normal or No Change

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	1	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

T3, Increase to High

Analysis denominator · Participants

Group	Source count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Calcium, Decrease to Low
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Calcium, Change to Normal or No Change
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Calcium, Increase to High
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants
title
Carbon dioxide, Decrease to Low
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants
title
Carbon dioxide, Change to Normal or No Change
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants
title
Carbon dioxide, Increase to High
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Chloride, Decrease to Low
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Chloride, Change to Normal or No Change
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants
title
Chloride, Increase to High
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
Direct bilirubin, Decrease to Low
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
Direct bilirubin, Change to Normal or No Change
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
Direct bilirubin, Increase to High

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
7
units
Participants

description

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

groups

description
Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
id
OG000
title
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation
description
Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
id
OG001
title
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation

param Type

COUNT_OF_PARTICIPANTS

population Description

All Treated Population. Only those participants with data available at specified time points have been analyzed.

reporting Status

POSTED

time Frame

Baseline (Day 1) and up to 31 months

title

Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice