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

NCT02488759

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 - Merkel Cell Cancer - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Cervical Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Nasopharyngeal Carcinoma
  • Vaginal Carcinoma
  • Vulvar Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
  • Official Title: Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA209-358
  • SECONDARY ID: 2015-000230-29
  • NCT ID: NCT02488759

Conditions

  • Various Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabNeoadjuvant Cohort
IpilimumabNivolumab plus Ipilimumab Cohort
RelatlimabBMS-986016, Anti-LAG 3Nivolumab plus Relatlimab Cohort
DaratumumabDarzalexNivolumab plus Daratumumab Cohort

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

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant CohortExperimentalNivolumab intravenous infusion as specified **Not participating: Japan, Korea, and Taiwan
  • Nivolumab
Metastatic Monotherapy CohortExperimentalNivolumab intravenous infusion as specified
  • Nivolumab
Nivolumab plus Ipilimumab CohortExperimentalNivolumab 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
  • Nivolumab
  • Ipilimumab
Nivolumab plus Relatlimab CohortExperimentalNivolumab 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
  • Nivolumab
  • Relatlimab
Nivolumab plus Daratumumab CohortExperimentalNivolumab 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
  • Nivolumab
  • Daratumumab

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The safety and tolerability will be measured by the incidence of drug-related adverse events (AEs) and serious adverse events (SAEs)
Time Frame:6 months after the last patient receives their first dose
Safety Issue:
Description:Rate of surgery delay which is defined as the proportion of subjects in the neoadjuvant cohort with surgery delayed > 4 weeks due to a drug related AE

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:Approximately 3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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