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

Trial Status: Closed to Accrual

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 - Merkel Cell Cancer - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type - Nasopharyngeal Cancer - No longer enrolling this tumor type - Head and Neck Cancer - No longer enrolling this tumor type

Inclusion Criteria

  • Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
  • Merkel Cell Carcinoma
  • Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
  • Nasopharyngeal Carcinoma
  • Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
  • Squamous cell carcinoma of the Head and Neck
  • Squamous cell carcinoma of the anal canal and penis
  • 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


Moffitt Cancer Center
Contact: Christine H. Chung
Phone: 813-745-5431


Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Ragini Reiney Kudchadkar
Phone: 404-778-4151


Johns Hopkins University / Sidney Kimmel Cancer Center
Contact: William Howard Sharfman
Phone: 410-955-6605


Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE


Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Christopher D. Lao
Phone: 734-647-8902

New York

New York
Memorial Sloan Kettering Cancer Center


Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE


University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Robert Louis Ferris
Phone: 412-648-6252


Fred Hutch / University of Washington Cancer Consortium
Contact: Shailender Bhatia
Phone: 206-288-2056

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-358
  • Secondary IDs NCI-2015-01356, 2015-000230-29
  • ID NCT02488759