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

Status: Active

Description

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

Eligibility Criteria

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

Locations & Contacts

Georgia

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

Maryland

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

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Name Not Available
Brigham and Women's Hospital
Status: Approved
Name Not Available
Dana-Farber Cancer Institute
Status: Approved
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Michigan

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

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

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

Washington

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

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-358
Secondary IDs NCI-2015-01356, 2015-000230-29
Clinicaltrials.gov ID NCT02488759