An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:October 8, 2015
End Date:December 31, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

The purpose of this study to investigate the safety and effectiveness of nivolumab, and
nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain
viruses have been known to play a role in tumor formation and growth. This study will
investigate the effects of the study drugs, in patients who have the following types of
tumors:

- Anal canal cancer-No longer enrolling this tumor type

- Cervical cancer

- Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type

- HPV positive and negative squamous cell cancer of the head and neck (SCCHN)

- Merkel Cell Cancer

- Nasopharyngeal cancer (NPC)

- Penile cancer-No longer enrolling this tumor type

- Vaginal and vulvar cancer-No longer enrolling this tumor type


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Histopathologic confirmation of the following tumor types (please refer to protocol
for full details pertaining to eligible tumor types):

1. Merkel Cell Carcinoma

2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor
type)

3. Nasopharyngeal Carcinoma

4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva

5. Squamous cell carcinoma of the Head and Neck

6. Squamous cell carcinoma of the anal canal and penis

7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with
surgery and/or radiation therapy who are unsuitable for platinum-based therapy
may enroll in the cervical cancer Combination B expansion cohort

- Measurable disease by CT or MRI

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)

- Men and women of age 18 or older

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Patients with active, known or suspected autoimmune disease

- Patients with a condition requiring systemic treatment with either corticosteroids or
other immunosuppressive medications

- Patients with hepatitis

- Patients with HIV

- Pregnant or breastfeeding women
We found this trial at
16
sites
Pittsburgh, Pennsylvania 15213
Phone: 412-648-6252
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-4000
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Boston, MA
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-5763
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-288-2056
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Phone: 734-647-8902
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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Atlanta, Georgia 30322
Phone: 404-778-4151
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Atlanta, GA
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Boston, Massachusetts 02215
Phone: 617-667-2100
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-1991
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Capital Federal, Buenos Aires
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Capital Federal,
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Charlotte, North Carolina 28211
Phone: 980-442-2314
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Charlotte, NC
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Lutherville, Maryland 21093
Phone: 410-955-6605
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Lutherville, MD
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New Orleans, Louisiana 70118
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New Orleans, LA
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New York, New York 10065
Phone: 646-888-5122
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New York, NY
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Oklahoma City, Oklahoma 73104
Phone: 405-271-8000
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Oklahoma City, OK
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Sioux Falls, South Dakota 57117
Phone: 558558099679
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Sioux Falls, SD
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Tampa, Florida 33612
Phone: 813-745-4780
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Tampa, FL
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