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 efficacy of using nivolumab to treat subjects who have virus-associated tumors. Certain viruses that infect human cells have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drug nivolumab in human subjects who have the following types of viral-associated tumors: Gastric Cancer, nasopharyngeal carcinoma , cervical cancer, vaginal cancer, vulvar cancer, squamous cell carcinoma of the head and neck, and Merkel Cell Carcinoma.

Inclusion Criteria:
• Histopathologic confirmation of the following tumor types:
-Merkel Cell Carcinoma
-Gastric or Gastro-Esophageal junction carcinoma
-Nasopharyngeal Carcinoma
-Squamous cell carcinoma of the cervix, vagina, or vulva
-Squamous cell carcinoma of the Head and Neck
• Measurable disease by CT or MRI

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
Phase I/II
Multiple Tumor Types
Rom Leidner, M.D.
BMS (Bristol-Myers Squibb)
Kim Sutcliffe
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside