NCT02443324 · OUTCOME

Phase 1a and 1b: Time to First Response (TTR)

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer · Source last updated 2024-07-31

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline to Date of CR or PR (Up to 24 Months)

What was measured

TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.

Analysis population: All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

Groups in this outcome

Cohort A and B

Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.

Cohort A1

Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

Cohort A2

Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

Cohort C

Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

Cohort D

Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

Cohort E

Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

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 A and B	3
Cohort A1	1
Cohort A2	7
Cohort C	8
Cohort D	3
Cohort E	11

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort A and B	1.4	Not reported	1.4	4.1	Not reported
Cohort A1	2.7	Not reported	NA	NA	Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.
Cohort A2	2.7	Not reported	1.3	2.8	Not reported
Cohort C	2.1	Not reported	1.3	3.0	Not reported
Cohort D	2.8	Not reported	1.3	5.5	Not reported
Cohort E	1.4	Not reported	1.2	3.0	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.4
upper Limit
4.1
value
1.4
comment
Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
2.7
group Id
OG002
lower Limit
1.3
upper Limit
2.8
value
2.7
group Id
OG003
lower Limit
1.3
upper Limit
3.0
value
2.1
group Id
OG004
lower Limit
1.3
upper Limit
5.5
value
2.8
group Id
OG005
lower Limit
1.2
upper Limit
3.0
value
1.4

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
7
group Id
OG003
value
8
group Id
OG004
value
3
group Id
OG005
value
11
units
Participants

description

TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.

dispersion Type

95% Confidence Interval

groups

description
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.
id
OG000
title
Cohort A and B
description
Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
id
OG001
title
Cohort A1
description
Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
id
OG002
title
Cohort A2
description
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
id
OG003
title
Cohort C
description
Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
id
OG004
title
Cohort D
description
Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
id
OG005
title
Cohort E

param Type

MEDIAN

population Description

All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

reporting Status

POSTED

time Frame

Baseline to Date of CR or PR (Up to 24 Months)

title

Phase 1a and 1b: Time to First Response (TTR)

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice