CompletedPhase 1NCT02572687

A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced 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).

Checked against the public recordLast updated Jan 20, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations28
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Ramucirumab; Drug: MEDI4736
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCLA Medical CenterSanta Monica, California
  • Johns Hopkins UniversityBaltimore, Maryland
  • Washington University Medical CenterSt Louis, Missouri
  • Carolinas Medical CenterCharlotte, North Carolina
  • The Miriam HospitalProvidence, Rhode Island
  • Vanderbilt University Medical CenterNashville, Tennessee
  • University of Texas MD Anderson Cancer CenterHouston, Texas
  • 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.Besançon
  • 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.Marseille
  • 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.Montpellier
  • 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.Saint-Etienne
  • 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.Großhansdorf

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2021. Always confirm current availability with the study team.

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