Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN

Phase 2

Completed

Conditions: Head and Neck Cancer Metastatic
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer

Brief Summary: Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).

Detailed Description: This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Patients with recurrent disease may have a limited number of sites of metastatic (spread) squamous cell carcinoma of head and neck. Another goal of this study is to learn how nivolumab impacts the immune system's ability to treat the cancer. While nivolumab is approved by the U. S. Food and Drug Administration (FDA) for the treatment of patients with metastatic SCCHN with progression on or after platinum-based chemotherapy, the word "investigational" in this context means that the study drugs are not approved by the FDA for the treatment of head and neck cancers prior to surgery and thus is still being tested in research studies. However, the FDA is allowing the use of nivolumab in this study.

This study will have two arms. Cohort (arm) 1 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Twelve patients will be enrolled to this arm. Cohort 2 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred and possibly spread to distant sites, but still can be resected with one surgery. Twelve patients will be enrolled to this arm.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Newly diagnosed SCCHN	Nivolumab 480mg and surgical resection	One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Recurrence of SCCHN	Nivolumab 480mg and surgical resection	One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.

Primary Outcome Measures

Name	Time	Method
Safety as Measured by Number of Participants With Drug-related Adverse Events	Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)	Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Feasibility as Measured by Number of Participants With Successful Completion of Preoperative Treatment and no Extended Treatment-related Delays	Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer per participant)	Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than \> 28 days from pre-planned day 0.

Secondary Outcome Measures

Name	Time	Method
Major Pathologic Response Rate	Day 0 (Surgery)	Number of participants with \< 10% residual tumor in the resection specimen.
Progression Free Survival (PFS)	up to 3 years	Number of months until radiologic or clinical progression or death, whichever occurs first.
Radiographic Response Rate	up to 4 weeks after the last dose of nivolumab	Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is \>= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is \>= 20% increase in the sum of the LD of target lesions. Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded.