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NCT02443324 · OUTCOME

Phase 1a and 1b: Overall Survival (OS)

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 Death from Any Cause (Up to 24 Months)

What was measured

The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.

Analysis population: All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 8; Cohort A1 = 8; Cohort A2 = 12; Cohort C = 12; Cohort D = 6 and Cohort E = 18. 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

GroupSource count
Cohort A and B41
Cohort A126
Cohort A228
Cohort C27
Cohort D24
Cohort E26

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A and B5.9Not reported4.410.6Not reported
Cohort A16.4Not reported4.213.3Not reported
Cohort A214.6Not reported5.4NAupper 95% confidence interval was not achieved due to high censoring rate.
Cohort C26.2Not reported11.8NAupper 95% confidence interval was not achieved due to high censoring rate.
Cohort D6.4Not reported2.518.7Not reported
Cohort ENANot reported13.2NAMedian and the upper 95% confidence interval was not achieved due to high censoring rate.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.4
        upper Limit
        10.6
        value
        5.9
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        13.3
        value
        6.4
      3. comment
        upper 95% confidence interval was not achieved due to high censoring rate.
        group Id
        OG002
        lower Limit
        5.4
        upper Limit
        NA
        value
        14.6
      4. comment
        upper 95% confidence interval was not achieved due to high censoring rate.
        group Id
        OG003
        lower Limit
        11.8
        upper Limit
        NA
        value
        26.2
      5. group Id
        OG004
        lower Limit
        2.5
        upper Limit
        18.7
        value
        6.4
      6. comment
        Median and the upper 95% confidence interval was not achieved due to high censoring rate.
        group Id
        OG005
        lower Limit
        13.2
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      28
    4. group Id
      OG003
      value
      27
    5. group Id
      OG004
      value
      24
    6. group Id
      OG005
      value
      26
    units
    Participants
description
The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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. Censored participants: Cohort A and B = 8; Cohort A1 = 8; Cohort A2 = 12; Cohort C = 12; Cohort D = 6 and Cohort E = 18. 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 Death from Any Cause (Up to 24 Months)
title
Phase 1a and 1b: Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice