A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies



Status:Active, not recruiting
Conditions:Lung Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:February 19, 2016
End Date:September 27, 2019

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An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies

The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in
participants with locally advanced and unresectable or metastatic gastrointestinal or
thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma,
non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).


Inclusion Criteria:

- Measurable metastatic disease or locally advanced and unresectable disease

- Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented
disease progression after 1-2 prior lines of systemic therapy

- Has histopathologically confirmed nonsquamous or squamous NSCLC with documented
disease progression after 1-3 prior lines of systemic therapy

- Has histopathologically or cytologically confirmed HCC, Child-Pugh Class A, with
documented disease progression during or after discontinuation of sorafenib
therapy, or intolerance of sorafenib therapy, and an α-fetoprotein (AFP) ≥ 1.5x
upper limit of normal

- Availability of tumor tissue for biomarker analysis

- Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Has adequate organ function

Exclusion Criteria:

- Has known brain metastases

- Has a history of prior cancers not included in this study that were either not treated
with curative intent or have been active within the past 5 years

- History of allogeneic organ transplant

- Has active or prior documented autoimmune disease within the past 24 months

- Has human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
(AIDS)-related illness, or a history of immunodeficiency

- Has active hepatitis B or hepatitis C infection, or co-infection with both hepatitis B
and C virus

- For gastric/GEJ and NSCLC participants, has chronic hepatitis B or hepatitis C
infection. (For HCC participants, those with chronic hepatitis B virus [HBV] infection
with a negative HBV deoxyribonucleic acid [DNA] test and who are on antiviral therapy,
and those with chronic hepatitis C virus [HCV] infection are eligible)

- Has a history of interstitial lung disease, idiopathic pulmonary fibrosis,
pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced
pneumonitis

- Has received any previous systemic therapy targeting programmed death (PD) 1 or
PD-ligand 1/2 signaling pathways, and other immune checkpoint inhibitors

- Have received previous systemic therapy with ramucirumab
We found this trial at
8
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Ronan Kelly
Phone: 410-502-1036
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Jimmy Hwang
Phone: 980-442-3105
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Charlotte, NC
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Laura Goff
Phone: 615-936-5184
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Besancon Cedex,
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Siqing Fu
Phone: 713-792-9669
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Howard Safran
Phone: 401-793-7151
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Providence, RI
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Saint Louis, Missouri 63110
Principal Investigator: A Lockhart
Phone: 314-747-4235
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Saint Louis, MO
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Santa Monica, California 90404
Principal Investigator: Zev Wainberg
Phone: 310-829-5471
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Santa Monica, CA
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