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Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer

NCT03575234 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-08-28

No results posted yet for this study

Summary

This phase I trial studies the side effects of nivolumab and IRX-2 and how well they work in treating participants with stage III-IVA oral cavity cancer or human papillomavirus (HPV)-positive oropharyngeal cancer that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. IRX-2 may "turn on" the immune system and stimulate an immune response against tumor cells. Giving nivolumab and IRX-2 followed by surgery may work better at treating oral cavity and oropharyngeal cancer.

Conditions

  • Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
  • Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

IRX-2

Given SC

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Surgery

Undergo surgery

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Brooklyn ImmunoTherapeutics, LLC

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Mihir Patel, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03575234 on ClinicalTrials.gov