NCT03575234

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

Phase I Neo-Adjuvant Nivolumab + IRX-2 Followed by Surgery for Resectable Oral Cavity Cancer or HPV-Associated Oropharynx Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety profile of combination immunotherapy, nivolumab + IRX-2, for HPV+ oropharyngeal squamous cell carcinoma (OPSCC) and HPV- oral cavity squamous cell carcinoma (OCSCC). II. To assess the oncologic efficacy of neo-adjuvant immunotherapy using pathologic confirmation of response after surgical resection. SECONDARY OBJECTIVES: I. To correlate tumor microenvironment histopathology with pathologic findings, with progression free survival (PFS) and other outcome parameters in patients with resectable OPSCC and OCSCC after the above treatments. II. To evaluate swallowing function before and after surgery and risk-adjusted adjuvant therapy. III. To evaluate quality of life (QOL), swallowing perception and performance, voice outcomes, and head and neck symptoms. OUTLINE: Participants receive nivolumab intravenously (IV) over 60 minutes on days 1 and 15, cyclophosphamide IV on day 1, and IRX-2 subcutaneously (SC) over 10 consecutive days between days 4-21 in the absence of disease progression or unacceptable toxicity. Beginning days 25-30, participants undergo surgery. After completion of study treatment, patients are followed up at 3 months, every 3 months for 2 years, then every 6 months for 2 years.

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

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
BIOLOGICAL	IRX-2	Given SC
BIOLOGICAL	Nivolumab	Given IV
PROCEDURE	Surgery	Undergo surgery

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2018-07-02
• Last updated: 2019-08-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study