A Study of Ramucirumab Plus Pembrolizumab in Participants... | NCT02443324 | Trialant
NCT02443324
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 31, 2024Actual
Enrollment
175Actual
Phase
Phase 1
Conditions
Gastric Adenocarcinoma
Adenocarcinoma of the Gastroesophageal Junction
Non-small Cell Lung Cancer
Carcinoma, Transitional Cell
Biliary Tract Cancer
Interventions
Ramucirumab
Pembrolizumab
Countries
United States
France
Germany
Japan
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02443324
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15787
Secondary IDs
ID
Type
Description
Link
I4T-MC-JVDF
Other Identifier
Eli Lilly and Company
2015-001473-40
EudraCT Number
KEYNOTE -098
Other Identifier
Merck
Brief Title
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
Official Title
An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 29, 2015Actual
Primary Completion Date
Aug 31, 2018Actual
Completion Date
Apr 12, 2022Actual
First Submitted Date
May 11, 2015
First Submission Date that Met QC Criteria
May 11, 2015
First Posted Date
May 13, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2023
Results First Submitted that Met QC Criteria
Feb 19, 2024
Results First Posted Date
Jul 31, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 19, 2024
Last Update Posted Date
Jul 31, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).
Detailed Description
Not provided
Conditions Module
Conditions
Gastric Adenocarcinoma
Adenocarcinoma of the Gastroesophageal Junction
Non-small Cell Lung Cancer
Carcinoma, Transitional Cell
Biliary Tract Cancer
Keywords
immuno-oncology
Vascular Endothelial Growth Factor (VEGF)
angiogenesis
PD-1
carcinoma of the bladder
carcinoma of the urethra
carcinoma of the ureter
carcinoma of the renal pelvis
carcinoma of the biliary tract
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
175Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A
Experimental
Participants with gastroesophageal junction (GEJ) cancer [Second-Third Line (L)] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort A1
Experimental
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.
Drug: Ramucirumab
Cohort A2
Experimental
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.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort B
Experimental
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.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort C
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ramucirumab
Drug
Administered IV
Cohort A
Cohort A1
Cohort A2
Cohort B
Cohort C
Cohort D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for >1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of > 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section.
Cycle 1 (21 Days)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Metastatic disease or locally advanced, unresectable disease.
Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Has adequate organ function.
Have an anticipated life expectancy of ≥3 months.
Exclusion Criteria:
Have known brain metastases.
Has received ≥3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ≥4 lines for NSCLC or urothelial cancer.
Has active autoimmune disease.
Known human immunodeficiency virus (HIV) infection.
Known active hepatitis B or hepatitis C infection.
Has received any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling pathways.
Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L. Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. J Thorac Oncol. 2021 Feb;16(2):289-298. doi: 10.1016/j.jtho.2020.10.004. Epub 2020 Oct 15.
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
Participants who did not "complete" study were those who discontinued study treatment by the time of study completion.
Recruitment Details
This study has Phase 1a (dose-limiting toxicity [DLT] observation) and expansion Phase 1b (safety and preliminary efficacy) included participants with 2 dosing schedules:
Schedule 1: gastroesophageal junction (GEJ) cancer (Cohorts A, A2) and biliary tract cancer (Cohorts A1); Schedule 2: Gastric-GEJ cancer (Cohort B), nonsmall cell lung cancer (NSCLC) (Cohorts C, E), and urothelial cancer (Cohort D).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A
Participants with Gastric-GEJ cancer [Second-Third Line (L)] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.
FG001
Cohort A1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 11, 2016
Mar 20, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort D
Experimental
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.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort E
Experimental
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.
Drug: Ramucirumab
Drug: Pembrolizumab
Cohort E
LY3009806
IMC-1121B
Cyramza
Pembrolizumab
Drug
Administered IV
Cohort A
Cohort A2
Cohort B
Cohort C
Cohort D
Cohort E
MK3475
Baseline to Measured Progressive Disease (Up to 24 Months)
Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered.
Baseline to Measured Progressive Disease (Up to 24 Months)
Phase 1a and 1b: Duration of Response (DoR)
The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Phase 1a and 1b: Time to First Response (TTR)
TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.
Baseline to Date of CR or PR (Up to 24 Months)
Phase 1a and 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Baseline to PD or Death of Any Cause (Up to 24 Months)
Phase 1a and 1b: Overall Survival (OS)
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.
Baseline to Death from Any Cause (Up to 24 Months)
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab
PK: Cmin of Ramucirumab following administration every 3 weeks.
Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24
Fort Myers
Florida
33916
United States
Florida Cancer Specialists and Research Institute
St. Petersburg
Florida
33705
United States
Tennessee Oncology PLLC
Chattanooga
Tennessee
37404
United States
Sarah Cannon Research Institute SCRI
Nashville
Tennessee
37203
United States
Tennessee Oncology PLLC
Nashville
Tennessee
37203
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dijon
21034
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille
59020
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon
69373
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris
75248
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dresden
01307
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Heidelberg
69126
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tübingen
72076
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kochi
780-0051
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yamanashi
400-0124
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona
08035
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid
28050
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pamplona
31008
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London
W1G 6AD
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manchester
M20 4BX
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sutton
SM2 5PT
United Kingdom
Derived
Herbst RS, Arkenau HT, Santana-Davila R, Calvo E, Paz-Ares L, Cassier PA, Bendell J, Penel N, Krebs MG, Martin-Liberal J, Isambert N, Soriano A, Wermke M, Cultrera J, Gao L, Widau RC, Mi G, Jin J, Ferry D, Fuchs CS, Petrylak DP, Chau I. Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial. Lancet Oncol. 2019 Aug;20(8):1109-1123. doi: 10.1016/S1470-2045(19)30458-9. Epub 2019 Jul 10.
Arkenau HT, Martin-Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). Oncologist. 2018 Dec;23(12):1407-e136. doi: 10.1634/theoncologist.2018-0044. Epub 2018 May 31.
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.
FG002
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.
FG003
Cohort B
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.
FG004
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.
FG005
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.
FG006
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.
FG00024 subjects
FG00126 subjects
FG00229 subjects
FG00317 subjects
FG00428 subjects
FG00524 subjects
FG00627 subjects
Received at Least One Dose of Study Drug
FG00024 subjects
FG00126 subjects
FG00228 subjects
FG00317 subjects
FG00427 subjects
FG00524 subjects
FG00626 subjects
Phase 1a
FG0008 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
Phase 1b
FG00016 subjects
FG00126 subjects
FG00228 subjects
FG00317 subjects
FG00424 subjects
FG00524 subjects
FG00626 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG0047 subjects
FG0050 subjects
FG0068 subjects
NOT COMPLETED
FG00024 subjects
FG00125 subjects
FG00225 subjects
FG00316 subjects
FG00421 subjects
FG00524 subjects
FG00619 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG0041 subjects
FG0053 subjects
FG0062 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0013 subjects
FG0025 subjects
FG0031 subjects
FG004
Progressive Disease
FG00020 subjects
FG00120 subjects
FG00213 subjects
FG00310 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Enrolled but Never Treated
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
All enrolled participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A
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.
BG001
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.
BG002
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.
BG003
Cohort B
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.
BG004
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.
BG005
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.
BG006
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.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00126
BG00228
BG00317
BG00427
BG00524
BG00626
BG007172
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00056.0(24.0 to 78.0)
BG00162.5(36.0 to 78.0)
BG00263.0(31.0 to 83.0)
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG00118
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for >1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of > 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section.
All enrolled participants who received at least one dose of the study drug in dose escalation phase and experienced a DLT. DLT was assessed in Phase 1a of Cohorts A and C during Cycle 1.
Posted
Number
participants
Cycle 1 (21 Days)
ID
Title
Description
OG000
Cohort A
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.
OG001
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.
Units
Counts
Participants
OG0006
OG0013
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
Secondary
Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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).
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Measured Progressive Disease (Up to 24 Months)
ID
Title
Description
OG000
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.
Secondary
Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered.
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).
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Measured Progressive Disease (Up to 24 Months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Phase 1a and 1b: Duration of Response (DoR)
The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
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).
Posted
Median
95% Confidence Interval
months
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
ID
Title
Description
OG000
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.
OG001
Cohort A1
Secondary
Phase 1a and 1b: Time to First Response (TTR)
TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.
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).
Posted
Median
95% Confidence Interval
months
Baseline to Date of CR or PR (Up to 24 Months)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
Phase 1a and 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 3; Cohort A1 = 4; Cohort A2 = 8; Cohort C = 10; Cohort D = 3 and Cohort E = 13. 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).
Posted
Median
95% Confidence Interval
months
Baseline to PD or Death of Any Cause (Up to 24 Months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Phase 1a and 1b: Overall Survival (OS)
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.
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).
Posted
Median
95% Confidence Interval
months
Baseline to Death from Any Cause (Up to 24 Months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab
PK: Cmin of Ramucirumab following administration every 3 weeks.
All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. PK was assessed both in Phase 1a and 1b as per protocol analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms/milliliter (μg/mL)
Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24
ID
Title
Description
OG000
Phase 1a: Gastric-GEJ or BTC
Participants 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.
OG001
Phase 1 a: Gastric, NSCLC, or Urothelial Patients
Participants 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.
OG002
Cohort A
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.
Time Frame
Baseline Up to 5.9 Years
Description
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A
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.
21
24
10
24
23
24
EG001
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.
19
26
15
26
26
26
EG002
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.
17
28
16
28
28
28
EG003
Cohort 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.
13
17
10
17
16
17
EG004
Cohort C
Participants with NSCLC (Second-Fourth 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.
16
27
15
27
27
27
EG005
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.
18
24
16
24
24
24
EG006
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.
9
26
14
26
26
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG0031 events1 affected17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected28 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Ventricular flutter
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected24 at risk
EG0012 events2 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected24 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected28 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected28 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected28 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected28 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Complication associated with device
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected28 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Obstruction
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Sudden death
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Empyema
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Meningitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0025 events3 affected28 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected28 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Urine output decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected28 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected28 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected28 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D014522
Urethral Diseases
D014515
Ureteral Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000096662
Ramucirumab
C582435
pembrolizumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0062 subjects
13 subjects
FG00517 subjects
FG00610 subjects
1 subjects
FG0050 subjects
FG0061 subjects
4 subjects
FG0053 subjects
FG0063 subjects
1 subjects
FG0050 subjects
FG0061 subjects
61.0
(28.0 to 73.0)
BG00465.0(34.0 to 82.0)
BG00563.0(45.0 to 87.0)
BG00663.0(42.0 to 85.0)
BG00761.28(24.0 to 87.0)
7
BG0033
BG0046
BG00510
BG00614
BG00765
Male
BG00017
BG0018
BG00221
BG00314
BG00421
BG00514
BG00612
BG007107
3
BG0032
BG0043
BG0054
BG0060
BG00720
Not Hispanic or Latino
BG00020
BG00119
BG00216
BG00312
BG00421
BG00510
BG00625
BG007123
Unknown or Not Reported
BG0002
BG0011
BG0029
BG0033
BG0043
BG00510
BG0061
BG00729
0
BG0030
BG0040
BG0050
BG0060
BG0071
Asian
BG0003
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0074
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0001
BG0010
BG0021
BG0030
BG0041
BG0050
BG0061
BG0074
White
BG00019
BG00123
BG00217
BG00316
BG00426
BG00522
BG00622
BG007145
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0001
BG0012
BG00210
BG0030
BG0040
BG0052
BG0063
BG00718
11
BG0038
BG0044
BG0058
BG00611
BG00747
United Kingdom
Title
Measurements
BG00015
BG00111
BG0027
BG0035
BG0042
BG0055
BG0066
BG00751
France
Title
Measurements
BG0002
BG0013
BG0027
BG0031
BG0048
BG0052
BG0062
BG00725
Germany
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0040
BG0051
BG0065
BG0078
Spain
Title
Measurements
BG0004
BG0019
BG0022
BG0033
BG00413
BG0058
BG0062
BG00741
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00041
OG00126
OG00228
OG00327
OG00424
OG00526
Title
Denominators
Categories
Title
Measurements
OG0007.3(1.5 to 19.9)
OG0013.8(0.1 to 19.6)
OG00225.0(10.7 to 44.9)
OG00329.6(13.8 to 50.2)
OG00412.5(2.7 to 32.4)
OG00542.3(23.4 to 63.1)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00041
OG00126
OG00228
OG00327
OG00424
OG00526
Title
Denominators
Categories
Title
Measurements
OG00051.2(35.1 to 67.1)
OG00138.5(20.2 to 59.4)
OG00267.9(47.6 to 84.1)
OG00385.2(66.3 to 95.8)
OG00450.0(29.1 to 70.9)
OG00584.6(65.1 to 95.6)
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0003
OG0011
OG0027
OG0038
OG0043
OG00511
Title
Denominators
Categories
Title
Measurements
OG0006.7(4.4 to 17.5)
OG0016.0(NA to NA)Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.
OG002NA(9.7 to NA)Median and the upper 95% confidence interval was not achieved due to high censoring rate.
OG003NA(11.1 to NA)Median and the upper 95% confidence interval was not achieved due to high censoring rate.
OG0048.3(4.6 to 16.8)
OG005NA(5.2 to NA)Median and the upper 95% confidence interval was not achieved due to high censoring rate.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0003
OG0011
OG0027
OG0038
OG0043
OG00511
Title
Denominators
Categories
Title
Measurements
OG0001.4(1.4 to 4.1)
OG0012.7(NA to NA)Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.
OG0022.7(1.3 to 2.8)
OG0032.1(1.3 to 3.0)
OG0042.8(1.3 to 5.5)
OG0051.4(1.2 to 3.0)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00041
OG00126
OG00228
OG00327
OG00424
OG00526
Title
Denominators
Categories
Title
Measurements
OG0002.5(1.5 to 4.2)
OG0011.6(1.4 to 2.8)
OG0025.6(2.7 to 11.5)
OG0039.7(4.6 to 27.6)
OG0041.9(1.2 to 2.8)
OG0059.3(4.0 to NA)upper 95% confidence interval was not achieved due to high censoring rate.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00041
OG00126
OG00228
OG00327
OG00424
OG00526
Title
Denominators
Categories
Title
Measurements
OG0005.9(4.4 to 10.6)
OG0016.4(4.2 to 13.3)
OG00214.6(5.4 to NA)upper 95% confidence interval was not achieved due to high censoring rate.
OG00326.2(11.8 to NA)upper 95% confidence interval was not achieved due to high censoring rate.
OG0046.4(2.5 to 18.7)
OG005NA(13.2 to NA)Median and the upper 95% confidence interval was not achieved due to high censoring rate.
OG003
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.
OG004
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.
OG005
Cohort 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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0006
OG0013
OG00216
OG00322
OG00426
OG00515
OG00623
OG00715
OG00821
Title
Denominators
Categories
Week 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG00216
ParticipantsOG00322
ParticipantsOG00426
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00050.9± 24
OG00244.2± 28
OG00345.2± 41
OG004
Week 3
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00320
Week 6
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG00311
Week 9
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
Week 12
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0032
Week 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Week 19
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Week 24
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0063 events2 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
4 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0052 events2 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
2 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
3 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
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EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG00415 events4 affected27 at risk
EG00510 events5 affected24 at risk
EG0069 events4 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected14 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected12 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected14 at risk
3 events
3 affected
17 at risk
EG00421 events11 affected27 at risk
EG0052 events2 affected24 at risk
EG0067 events6 affected26 at risk
0 events
0 affected
17 at risk
EG0046 events5 affected27 at risk
EG0051 events1 affected24 at risk
EG0062 events2 affected26 at risk
3 events
3 affected
17 at risk
EG00411 events8 affected27 at risk
EG0051 events1 affected24 at risk
EG0067 events7 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
17 at risk
EG0047 events5 affected27 at risk
EG0051 events1 affected24 at risk
EG0065 events5 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0045 events3 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0063 events2 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0052 events1 affected24 at risk
EG0064 events3 affected26 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0048 events4 affected27 at risk
EG0052 events2 affected24 at risk
EG0069 events6 affected26 at risk
3 events
2 affected
17 at risk
EG0043 events2 affected27 at risk
EG0051 events1 affected24 at risk
EG0063 events3 affected26 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG00611 events5 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
17 at risk
EG0042 events2 affected27 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
8 events
4 affected
17 at risk
EG00412 events9 affected27 at risk
EG0059 events7 affected24 at risk
EG00615 events6 affected26 at risk
1 events
1 affected
17 at risk
EG0042 events1 affected27 at risk
EG0051 events1 affected24 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected27 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected26 at risk
45.9
± 23
Participants
OG004
22
ParticipantsOG00515
ParticipantsOG00623
ParticipantsOG00715
ParticipantsOG00821
Title
Measurements
OG00052± 29
OG00120.9± 35
OG00240± 48
OG00344.1± 57
OG00445.2± 32
OG00513.3± 93
OG00622.5± 62
OG00720.9± 54
OG00815.6± 70
Participants
OG004
18
ParticipantsOG00512
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00818
Title
Measurements
OG00069± 29
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 21.2 μg/mL, 30.6 μg/mL
OG00279.8± 30
OG00369.1± 68
OG00461± 38
OG00525.7± 74
OG00633.8± 68
OG00723.3± 102
OG00819.3± 115
Participants
OG004
13
ParticipantsOG0059
ParticipantsOG00618
ParticipantsOG00711
ParticipantsOG00815
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 45.6 μg/mL, 72.5 μg/mL
OG00132.7± 20.6
OG00272.8± 46
OG00394.3± 40
OG00478.8± 31
OG00532.7± 60
OG00640.1± 63
OG00734.8± 73
OG00828.6± 90
Participants
OG004
10
ParticipantsOG0058
ParticipantsOG00616
ParticipantsOG0078
ParticipantsOG00810
Title
Measurements
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 26.9 μg/mL, 38.7 μg/mL
OG00289.3± 35
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 140 μg/mL, 160 μg/mL
OG00480.2± 38
OG00536.8± 48
OG00647.1± 45
OG00734.9± 141
OG00826.3± 89
Participants
OG004
7
ParticipantsOG0054
ParticipantsOG00611
ParticipantsOG0075
ParticipantsOG0089
Title
Measurements
OG00292.4± 71
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 147 μg/mL, 171 μg/mL
OG00487.6± 48
OG00552.7± 45
OG00644.4± 31
OG00752.6± 36
OG00837.1± 66
Participants
OG004
5
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG002149± 69
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 215 μg/mL
OG004120± 34
Participants
OG004
3
ParticipantsOG0054
ParticipantsOG00610
ParticipantsOG0072
ParticipantsOG0087
Title
Measurements
OG002116± 83
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 178 μg/mL
OG00495.7± 27
OG00543.6± 40
OG00645± 29
OG007NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 39.5 μg/mL, 88 μg/mL