Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03575234|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cyclophosphamide Biological: IRX-2 Biological: Nivolumab Procedure: Surgery||Phase 1 Phase 2|
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.
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: Fifteen subjects with HPV-related oropharynx HNSCC (cohort 1) and 15 subjects with HPV-negative oral cavity HNSCC (cohort 2) patients will be included. Patients will take nivolumab on days 1 and 15 and IRX-2 for 10 days between days 4-21. Patients will have surgery to remove their cancer between days 25-30 (for oropharynx cancer this will be via transoral robotic surgery, TORS). Treatment after surgery will depend on institutional guidelines.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Neo-Adjuvant Nivolumab + IRX-2 Followed by Surgery for Resectable Oral Cavity Cancer or HPV-Associated Oropharynx Cancer|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||January 31, 2025|
Experimental: Cohort 1: HPV-Related Oropharynx SCC
HPV-positive oropharynx cancer patients receive nivolumab IV over 60 minutes on days 1 and 15, cyclophosphamide IV on day 1, and IRX-2 SC over 10 consecutive days between days 4-21 in the absence of disease progression or unacceptable toxicity. Beginning days 25-30, patients undergo surgery.
Given subcutaneously (SC)
Experimental: Cohort 2: HPV-Negative Oral Cavity SCC
HPV-negative oral cavity cancer patients receive nivolumab IV over 60 minutes on days 1 and 15, cyclophosphamide IV on day 1, and IRX-2 SC over 10 consecutive days between days 4-21 in the absence of disease progression or unacceptable toxicity. Beginning days 25-30, patients undergo surgery.
Given subcutaneously (SC)
- Incidence of adverse events (AEs) described using Common Terminology Criteria for Adverse Events 4.03 [ Time Frame: Up to 4 years ]Non-hematologic toxicities will be evaluated via the ordinal Common Toxicity Criteria (CTC) standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized.
- Change in tumor size determined by central radiology review by radiologists blinded to the treatment regimen [ Time Frame: Baseline up to 4 years ]Tumor changes will be determined by a comparison of the imaging studies (contrast-enhanced computed tomography [CECT] or magnetic resonance imaging [MRI]) obtained pre-treatment and just prior to surgery. Percent changes in tumor size will be determined by radiology at the site. If the change is not clear to the radiologist at the site, then the PI must be notified and two radiologists at Emory will be asked to independently review the scans and a decision will be made.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575234
|Contact: Mihir Patel, MDemail@example.com|
|United States, Georgia|
|Emory University Hospital Midtown||Not yet recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Swathi Chinaranagari 404-686-0239 firstname.lastname@example.org|
|Emory University Hospital/Winship Cancer Institute||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Shantina Walls 404-778-4995 email@example.com|
|Principal Investigator:||Mihir Patel, MD||Emory University|