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BRIEF TITLE: 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

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


  • Org Study ID: 15787
  • Secondary ID: I4T-MC-JVDF,2015-001473-40,KEYNOTE -098
  • NCT ID: NCT02443324
  • NCT Alias:
  • Sponsor: Eli Lilly and Company - Industry
  • Source: Eli Lilly and Company

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).

Overal Status Start Date Phase Study Type
Recruiting July 29, 2015 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Primary Outcome 1 - Time Frame: Baseline to Measured Progressive Disease (Estimated up to 24 Months)

Condition:

  • Gastric Adenocarcinoma
  • Adenocarcinoma of the Gastroesophageal Junction
  • Non-small Cell Lung Cancer
  • Carcinoma, Transitional Cell
  • Biliary Tract Cancer

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: 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)

Role: Study Director

Affiliation: Eli Lilly and Company

Overall Contact

Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email:

Link: Click here for more information about this study: A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Locations

Facility Status Contact
Yale University School of Medicine
New Haven, Connecticut 06520-8020
United States
Recruiting
203-737-5649
Florida Cancer Specialists
Fort Myers, Florida 33916
United States
Recruiting
239-274-9930
Florida Cancer Specialists and Research Institute
Saint Petersburg, Florida 33705
United States
Recruiting
727-216-1143
Tennessee Oncology PLLC
Chattanooga, Tennessee 37404
United States
Recruiting
423-698-1844
Sarah Cannon Research Institute SCRI
Nashville, Tennessee 37203
United States
Recruiting
615-329-7274
Tennessee Oncology PLLC
Nashville, Tennessee 37203
United States
Recruiting
615-329-7274
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting
206-288-2048
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 Cedex, 21034
France
Recruiting Eli Lilly and Company

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 Cedex, 59020
France
Recruiting Eli Lilly and Company

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 Cedex 08, 69373
France
Recruiting Eli Lilly and Company

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 CEDEX 05, 75248
France
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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-Shi, 780-0051
Japan
Not yet recruiting Eli Lilly and Company

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
Not yet recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company

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
Recruiting Eli Lilly and Company