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

NCT02488759 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2023-11-13

Study results available
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Summary

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

Conditions

  • Various Advanced Cancer

Interventions

DRUG

Nivolumab

DRUG

Ipilimumab

DRUG

Relatlimab

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2021-03-19
Completion
2022-10-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Japan
  • Mexico
  • Netherlands
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488759 on ClinicalTrials.gov