Clinical Trial: NCT02488759 - My Cancer Genome

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 - Nasopharyngeal Cancer - No longer enrolling this tumor type - Head and Neck 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:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02488759

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

Drug	Synonyms	Arms
Nivolumab		Metastatic Monotherapy Cohort
Ipilimumab		Nivolumab plus Ipilimumab Cohort
Relatlimab	BMS-986016, Anti-LAG 3	Nivolumab plus Relatlimab Cohort
Daratumumab	Darzalex	Nivolumab plus Daratumumab Cohort

Purpose

Trial Arms

Name	Type	Description	Interventions
Neoadjuvant Cohort	Experimental	Nivolumab intravenous infusion as specified **Not participating: Japan, Korea, and Taiwan	Nivolumab
Metastatic Monotherapy Cohort	Experimental	Nivolumab intravenous infusion as specified	Nivolumab
Nivolumab plus Ipilimumab Cohort	Experimental	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	Nivolumab Ipilimumab
Nivolumab plus Relatlimab Cohort	Experimental	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	Nivolumab Relatlimab
Nivolumab plus Daratumumab Cohort	Experimental	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	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:

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:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

September 10, 2020

Clinical Trials /

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