Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Tremelimumab

Ipilimumab

Antineoplastic Agents, Immunological

Immunologic Factors

Immune Checkpoint Inhibitors

Participants receive durvalumab IV over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.

Participants receive durvalumab IV over 1 hour and tremelimumab IV over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.

Renata Ferrarotto

This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To assess the differences between CD8+ tumor infiltrating lymphocytes evaluated by immunohistochemistry staining in the post-treatment surgical specimens as compared to baseline in patients treated with durvalumab single agent compared with patients receiving durvalumab plus tremelimumab.

SECONDARY OBJECTIVES:

I. Safety and toxicity of durvalumab single agent or combined with tremelimumab administered every 4 weeks for 2 doses in the preoperative setting according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

II. Objective Response rate at 8 weeks, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

III. Percentage of patients undergoing the initially proposed surgery at 4 weeks.

IV. Percentage of patients undergoing the initially proposed surgery at 8 weeks.

V. Percentage of viable tumor cells in the surgical specimen. VI. Patient-reported outcomes (PRO) during treatment with checkpoint inhibitors.

EXPLORATORY OBJECTIVES:

I. To assess pre- and post- treatment tumor, blood and oral rinse based immune biomarkers.

II. Correlate tissue and blood-based biomarkers with human papillomavirus (HPV) status, outcomes and toxicity.

OUTLINE: Participants are randomized into 1 of 2 cohorts.

COHORT I: Participants receive durvalumab intravenously (IV) over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.

COHORT II: Participants receive durvalumab IV over 1 hour and tremelimumab IV over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.

After completion of study treatment, participants are followed up at 28 and 42 days, 4 and 6 months, and then periodically for up to 5 years.

Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer

Checkpoint Inhibitors Assessment in Oropharynx Carcinoma (CIAO)

Change will be defined as the ratio of the CD8+ lymphocytes density in the post-treatment surgical specimens over the CD8+ density in the baseline biopsy before treatment.

Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1.

The Mean MD Anderson Symptom Inventory Head and Neck Cancer (MDASI-HN) is a 28-item patient-reported outcomes questionnaire developed to measure severity or burden of systemic and head and neck squamous cell carcinoma (HNSCC)-specific symptoms and their interference with patients' daily functioning. Each symptoms is rated from 0 (not present) to 10 (as bad as you can imagine).

Spots Global Cancer Trial Database for stage ii oropharyngeal squamous cell carcinoma ajcc v6 and v7