A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:September 24, 2018
End Date:October 25, 2024
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:ClinicalTrials@bms.com
Phone:please email

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Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

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)


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologic or cytologic confirmation of advanced (metastatic and/or unresectable)
solid tumors of one of the following tumor types:

1. Metastatic squamous or non-squamous NSCLC

2. RCC, advanced or metastatic

3. Melanoma

4. HCC

5. CRC, metastatic (MSI-H or dMMR)

- 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 could apply
We found this trial at
12
sites
Minneapolis, Minnesota 55416
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Minneapolis, MN
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Atlanta, Georgia 30322
Phone: 404-778-5680
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Atlanta, GA
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Austin, Texas 78705
Phone: 972-841-8345
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Austin, TX
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Beaumont, Texas 77702
Phone: 281-863-6778
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Beaumont, TX
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Charlotte, North Carolina 28211
Phone: 980-442-2384
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Charlotte, NC
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Dallas, Texas 75246
Phone: 281-863-6778
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Dallas, TX
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Detroit, Michigan 48201
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Detroit, MI
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Eugene, Oregon 97401
Phone: 281-863-6778
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Eugene, OR
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Greenville, South Carolina 29615
Phone: 281-863-6778
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Greenville, SC
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Porto Alegre, Rio Grande do Sul 90470
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Porto Alegre,
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Rockville, Maryland 20852
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Rockville, MD
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Tyler, Texas 75702
Phone: 281-863-6778
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Tyler, TX
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