Clinical Trial 18527

Cancer Type: Multiple
Interventions:BMS-936558 (Nivolumab); Ipilimumab; Nivolumab; Not Applicable; Yervoy (Ipilimumab)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Christine Chung

Overview

Study Title

Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherpay and Nivolumab Combination Therapy in Subjects with Virus-Positive and Virus-Negative Solid Tumors

Summary

The purpose of this study to investigate the safety and efficacy of using nivolumab to treat participants who have virus-associated tumors. Certain viruses that infect human cells have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drug nivolumab in participants who have the following types of viral-associated tumors: Gastric Cancer, nasopharyngeal carcinoma , cervical cancer, vaginal cancer, vulvar cancer, squamous cell carcinoma of the head and neck, and Merkel Cell Carcinoma.

Objective

In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the applicable tumor types. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the applicable diseases.

Inclusion Criteria

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  • Histopathologic confirmation of the following tumor types: Merkel Cell Carcinoma; Gastric or Gastro-Esophageal junction carcinoma; Nasopharyngeal Carcinoma; Squamous cell carcinoma of the cervix, vagina, or vulva; Squamous cell carcinoma of the Head and Neck
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
  • Men and women of age 18 or older

  • Exclusion Criteria

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  • Active brain metastases or leptomeningeal metastases
  • Active, known or suspected autoimmune disease
  • A condition requiring systemic treatment with either corticosteroids
  • Hepatitis or HIV
  • Women who are pregnant or breastfeeding