NCT03278782 · OUTCOME

Evaluate the Safety of Pembrolizumab in Combination With Romidepsin.

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin · Source last updated 2026-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: 7 years and 4 months

What was measured

Estimate the response rate of the combination therapy in refractory or recurrent PTCL.

Analysis population: This is a phase Ib/II study, it was more safety run-in for Ib followed by phase II. This is a single arm trial. We have shown the calculation and how the 47% uses 38 as denominator for responders and the denominator for TfH/AITL to calculate the number. We are calculating ORR for the whole and the subset so the denominators will have to be different and hence the TfH subtype will have higher ORR because of higher number of patients with CR when comparing them within the TfH cohort.

Groups in this outcome

Cohort 1

Pembrolizumab 200mg IV D1 + Romidepsin 14mg/m² IV D1, D8 q21d

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
Cohort 1	38

Reported measurements

Overall Response Rate in Intent to Treat population

Analysis denominator · Participants

Group	Source count
Cohort 1	38

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	47.3	Not reported	Not reported	Not reported	Not reported

Overall Response Rate in TFH-phenotype lymphomas

Analysis denominator · Participants

Group	Source count
Cohort 1	14

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	61.5	Not reported	Not reported	Not reported	Not reported

Complete Response

Analysis denominator · Participants

Group	Source count
Cohort 1	14

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	53.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
47.3
denoms
counts
group Id
OG000
value
38
units
Participants
title
Overall Response Rate in Intent to Treat population
categories
measurements
group Id
OG000
value
61.5
denoms
counts
group Id
OG000
value
14
units
Participants
title
Overall Response Rate in TFH-phenotype lymphomas
categories
measurements
group Id
OG000
value
53.8
denoms
counts
group Id
OG000
value
14
units
Participants
title
Complete Response

denoms

counts
group Id
OG000
value
38
units
Participants

description

Estimate the response rate of the combination therapy in refractory or recurrent PTCL.

groups

description
Pembrolizumab 200mg IV D1 + Romidepsin 14mg/m² IV D1, D8 q21d
id
OG000
title
Cohort 1

param Type

NUMBER

population Description

This is a phase Ib/II study, it was more safety run-in for Ib followed by phase II. This is a single arm trial. We have shown the calculation and how the 47% uses 38 as denominator for responders and the denominator for TfH/AITL to calculate the number. We are calculating ORR for the whole and the subset so the denominators will have to be different and hence the TfH subtype will have higher ORR because of higher number of patients with CR when comparing them within the TfH cohort.

reporting Status

POSTED

time Frame

7 years and 4 months

title

Evaluate the Safety of Pembrolizumab in Combination With Romidepsin.

type

PRIMARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice