A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal o… (NCT02572687) | Clinical Trial Compass
CompletedPhase 1
A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies
United States85 participantsStarted 2016-02-19
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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, tho…
What they're measuring
1
Number of Participants with Dose Limiting Toxicities (DLTs)