NCT03656718
Recruiting
September 4, 2018
May 9, 2022
Brief 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).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20 |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Permeation enhancer Biological: nivolumab (IV) Specified Dose on Specified Days |
Experimental: Part B, Group 2: nivolumab (dose 1) |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Biological: nivolumab (IV) Specified Dose on Specified Days |
Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20 |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Permeation enhancer Biological: nivolumab (IV) Specified Dose on Specified Days |
Experimental: Part B, Group 4: nivolumab (dose 2) |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Biological: nivolumab (IV) Specified Dose on Specified Days |
Experimental: Part C: nivolumab (dose 3) + rHuPH20 |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Permeation enhancer |
Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20 |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Permeation enhancer |
Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20 |
Biological: nivolumab (Subcutaneous) Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Permeation enhancer |
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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Georgia
Local Institution
Atlanta
United States, Maryland
Maryland Oncology Hematology, P.A.
Rockville
United States, Michigan
Karmanos Cancer Institute
Detroit
United States, Minnesota
Local Institution
Minneapolis
United States, North Carolina
Levine Cancer Institute
Charlotte
United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene
United States, South Carolina
Local Institution
Greenville
United States, Texas
Texas Oncology- Austin Midtown
Austin
United States, Texas
Texas Oncology-Beaumont
Beaumont
United States, Texas
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas
United States, Texas
Uus Oncology
Tyler
Argentina
Local Institution
Caba
Argentina
Local Institution
Caba
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil
Local Institution - 0037
Sao Paulo
Chile, Metropolitana
Local Institution
Santiago
Chile
Clinica San Carlos de Apoquindo
Santiago
France
Institut De Cancerologie De L Ouest
Saint Herblain
France
Institut Gustave Roussy
Villejuif
Italy
Local Institution - 0004
Padova
Italy
Local Institution
Rozzano
Netherlands
Local Institution
Amsterdam
Netherlands
Local Institution - 0039
Maastricht
New Zealand, Wellington
Local Institution
Newtown
New Zealand
Local Institution - 0014
Dunedin
New Zealand
Local Institution - 0015
Tauranga
Poland, Mazowieckie
Local Institution - 0019
Warszawa
Spain
Local Institution - 0017
Madrid
Spain
Hospital Universitario Virgen De La Victoria
Malaga
United Kingdom, Glamorgan
Local Institution
Cardiff
United Kingdom
Local Institution
Cambridge
United Kingdom
Local Institution
Leicester
United Kingdom
Local Institution
Liverpool
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb