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Recruiting

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors - CA209-358

Updated: 10 July, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 21

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Metastatic Monotherapy Cohort
Drug: Nivolumab
Experimental: Neoadjuvant Cohort
Drug: Nivolumab
Experimental: Nivolumab plus Daratumumab Cohort
Drug: Nivolumab Drug: Daratumumab
Experimental: Nivolumab plus Ipilimumab Cohort
Drug: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab plus Relatlimab Cohort
Drug: Nivolumab Drug: Relatlimab

Key Eligibility Criteria

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 of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penile - 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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us