Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT03575234
Status:
WITHDRAWN
Last Update Posted:
2019-08-28
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Phase I Neo-Adjuvant Nivolumab + IRX-2 Followed by Surgery for Resectable Oral Cavity Cancer or HPV-Associated Oropharynx Cancer
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding and drug were withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: