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At this time, this protocol is recruiting patients for Cervical Cancer and Merkel Cell Carcinoma only.

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: 19 April, 2019   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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.
Print this page CA209-358
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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 24

    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: Daratumumab Drug: Nivolumab
Experimental: Nivolumab plus Ipilimumab Cohort
Drug: Ipilimumab Drug: Nivolumab
Experimental: Nivolumab plus Relatlimab Cohort
Drug: Relatlimab Drug: Nivolumab

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 (SCC) of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penis 7. 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

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