Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 Clinical Trial
Official title:
Phase I Neo-Adjuvant Nivolumab + IRX-2 Followed by Surgery for Resectable Oral Cavity Cancer or HPV-Associated Oropharynx Cancer
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02381535 -
Onalespib in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck Receiving Radiation Therapy and Cisplatin
|
Phase 1 | |
| Completed |
NCT02775812 -
Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
|
Phase 1 | |
| Terminated |
NCT02917629 -
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
|
Phase 2 | |
| Recruiting |
NCT01810913 -
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
|
Phase 2/Phase 3 | |
| Suspended |
NCT04411121 -
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-risk Head and Neck Cancer
|
Phase 2/Phase 3 | |
| Terminated |
NCT03601507 -
Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer
|
Phase 2 | |
| Recruiting |
NCT03799445 -
Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT03144778 -
Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT01893307 -
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT01935921 -
Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02567422 -
Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer
|
Phase 1 |