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

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

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000