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).

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT03656718

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 35 Locations for this study

See Locations Near You

Winship Cancer Institute.
Atlanta Georgia, 30322, United States
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Willamette Valley Cancer Institute And Research Center
Eugene Oregon, 97401, United States
Local Institution
Greenville South Carolina, 29605, United States
Texas Oncology- Austin Midtown
Austin Texas, 78705, United States
Texas Oncology-Beaumont
Beaumont Texas, 77702, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas Texas, 75246, United States
Uus Oncology
Tyler Texas, 75702, United States
Local Institution - 0043
Buenos Aires , C1419, Argentina
Local Institution - 0035
Caba , 1199, Argentina
Local Institution - 0025
Caba , 1426, Argentina
Local Institution
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0037
Sao Paulo , 05651, Brazil
Local Institution
Santiago Metropolitana, , Chile
Local Institution - 0041
Santiago Región Metropolitana De Santiago, 75100, Chile
Local Institution - 0042
Santiago Región Metropolitana De Santiago, 84203, Chile
Local Institution - 0005
Santiago , 0, Chile
Institut De Cancerologie De L Ouest
Saint Herblain , 44805, France
Local Institution - 0021
Villejuif , 94805, France
Istituto Oncologico Veneto IOV
Padova , 35128, Italy
Local Institution - 0003
Rozzano , 20089, Italy
Local Institution - 0046
Monterrey Nuevo León, 64710, Mexico
Local Institution - 0047
Monterrey Nuevo León, 66460, Mexico
Local Institution - 0045
Querétaro , 76000, Mexico
Local Institution - 0026
Amsterdam , 1066 , Netherlands
Local Institution - 0039
Maastricht , 6229 , Netherlands
Local Institution - 0018
Newtown Wellington, 6021, New Zealand
Local Institution - 0014
Dunedin , 9012, New Zealand
Local Institution - 0015
Tauranga , 3112, New Zealand
Local Institution - 0019
Warszawa Mazowieckie, 02-78, Poland
Local Institution - 0017
Madrid , 28007, Spain
Local Institution - 0016
Malaga , 29010, Spain
Local Institution
Cardiff Glamorgan, CF14 , United Kingdom
Local Institution - 0031
Liverpool , L7 8Y, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT03656718

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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