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

Conditions

• Various Advanced Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
• Ipilimumab — DRUG
• Relatlimab — DRUG
• Daratumumab — DRUG

Study Details

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

Key Dates

Start date

Oct 13, 2015

Status verified

Nov 2023

Primary completion

Mar 19, 2021

Completion

Oct 24, 2022

Study Design

Enrollment

578 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) [ Time Frame: From first dose to 30 days post last dose (Up to 2 months) ]

Locations (14)

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