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

Completed · Phase 1/Phase 2

Conditions studied: Various Advanced Cancer

In brief

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

Key facts

Study ID

NCT02488759

Run by

Bristol-Myers Squibb

People needed

578

Starts

2015-10-13

Expected to finish

2022-10-24

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0033 — Tampa, Florida, United States
• Local Institution - 0003 — Atlanta, Georgia, United States
• Local Institution - 0023 — Lutherville, Maryland, United States
• Local Institution - 0002 — Boston, Massachusetts, United States
• Local Institution - 0019 — Boston, Massachusetts, United States
• Local Institution - 0020 — Boston, Massachusetts, United States
• Local Institution - 0035 — Ann Arbor, Michigan, United States
• Local Institution - 0036 — New York, New York, United States
• Local Institution - 0022 — Charlotte, North Carolina, United States
• Local Institution - 0005 — Oklahoma City, Oklahoma, United States
• Local Institution - 0004 — Portland, Oregon, United States
• Local Institution - 0029 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0001 — Sioux Falls, South Dakota, United States
• Local Institution - 0021 — Seattle, Washington, United States
• Local Institution - 0012 — Brussels, Belgium
• Local Institution - 0014 — Brussels, Belgium
• Local Institution - 0013 — Brussels, Belgium
• Local Institution - 0031 — Marseille, France
• Local Institution - 0038 — Paris, France
• Local Institution - 0032 — Toulouse, France
• Local Institution - 0030 — Vlllejuif, France
• Local Institution - 0027 — Essen, Germany
• Local Institution - 0028 — Heilbronn, Germany
• Local Institution - 0039 — Kashiwa-shi, Chiba, Japan
• Local Institution - 0040 — Chuo-ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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