Melanoma Clinical Trial
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Summary
The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.
This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:
non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
unresectable or metastatic melanoma
hepatocellular carcinoma (HCC)
microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
Metastatic squamous or non-squamous NSCLC
RCC, advanced or metastatic
Melanoma
HCC
CRC, metastatic (MSI-H or dMMR)
In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
In Part E, Metastatic urothelial carcinoma
Measurable disease as per RECIST version 1.1 criteria
ECOG performance status of 0 or 1
Exclusion Criteria:
Active brain metastases or leptomeningeal metastases
Ocular melanoma
Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
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There are 35 Locations for this study
Atlanta Georgia, 30322, United States
Rockville Maryland, 20850, United States
Detroit Michigan, 48201, United States
Charlotte North Carolina, 28204, United States
Eugene Oregon, 97401, United States
Greenville South Carolina, 29605, United States
Austin Texas, 78705, United States
Beaumont Texas, 77702, United States
Dallas Texas, 75246, United States
Tyler Texas, 75702, United States
Caba , 1199, Argentina
Caba , 1426, Argentina
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Sao Paulo , 05651, Brazil
Santiago Metropolitana, , Chile
Santiago , 0, Chile
Saint Herblain , 44805, France
Villejuif , 94805, France
Padova , 35128, Italy
Rozzano , 20089, Italy
Mexico City Distrito Federal, 03100, Mexico
Mexico City Distrito Federal, 14080, Mexico
Monterrey Nuevo León, 64710, Mexico
Monterrey Nuevo León, 66460, Mexico
Puebla , 72424, Mexico
Querétaro , 76000, Mexico
Amsterdam , 1066 , Netherlands
Maastricht , 6229 , Netherlands
Newtown Wellington, 6021, New Zealand
Dunedin , 9012, New Zealand
Tauranga , 3112, New Zealand
Warszawa Mazowieckie, 02-78, Poland
Madrid , 28007, Spain
Malaga , 29010, Spain
Cardiff Glamorgan, CF14 , United Kingdom
Liverpool , L7 8Y, United Kingdom
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