An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Purpose
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
Condition
- Various Advanced Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Neoadjuvant Cohort |
Nivolumab intravenous infusion as specified **Not participating: Japan, Korea, and Taiwan |
|
Experimental Metastatic Monotherapy Cohort |
Nivolumab intravenous infusion as specified |
|
Experimental Nivolumab plus Ipilimumab Cohort |
Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified **Not participating: Belgium, France and Germany Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico **Not participating in cohort expansion: France, Germany, Korea and Taiwan |
|
Experimental Nivolumab plus Relatlimab Cohort |
Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified ** Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort |
|
Experimental Nivolumab plus Daratumumab Cohort |
Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified **Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort |
|
More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb