A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:July 29, 2015
End Date:August 31, 2019

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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

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).


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.
We found this trial at
8
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Roy Herbst
Phone: 203-737-5649
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Andres Soriano
Phone: 239-274-9930
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Fort Myers, FL
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Rafael Santana-Davila
Phone: 206-288-2048
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Chattanooga, Tennessee 37404
Principal Investigator: Edward Arrowsmith
Phone: 423-698-1844
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Chattanooga, TN
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Dijon Cedex,
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Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Saint Petersburg, Florida 33705
Principal Investigator: Jennifer Cultrera
Phone: 727-216-1143
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Saint Petersburg, FL
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