Lung Cancer Clinical Trial
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
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).
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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There are 21 Locations for this study
New Haven Connecticut, 06520, United States
Fort Myers Florida, 33916, United States
Saint Petersburg Florida, 33705, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Seattle Washington, 98109, United States
Dijon Cedex , 21034, France
Lille Cedex , 59020, France
Lyon Cedex 08 , 69373, France
Paris CEDEX 05 , 75248, France
Dresden , 01307, Germany
Heidelberg , 69126, Germany
Tübingen , 72076, Germany
Kochi-Shi , 780-0, Japan
Yamanashi , 400-0, Japan
Barcelona , 08035, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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