Squamous Cell Cancer of the Head and Neck

Primary Objective  To compare PFS and OS of Nivolumab to Investigator’s Choice in subjects who have tumor progression within 6 months of last dose of platinum therapy in the primary, recurrent, or Secondary Objectives  To compare Objective Response Rate (ORR) of Nivolumab to Investigator’s Choice.

Nivolumab

Nivolumab

Injection

100
100 mg/Vial

Primary Outcome Measures :
1. Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint [ Time Frame: From date of randomization to date of death, approximately 18 months ]
Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.

2. Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization to 3, 6, 9, and 12 months ]
The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.


Secondary Outcome Measures :
1. Progression-Free Survival (PFS) [ Time Frame: Randomization to disease progression or death, whichever occurs first; Approximately 5 years ]
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.

2. Objective Response Rate (ORR) [ Time Frame: Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years ]
ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.

Inclusion Criteria:
• Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
• Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
• Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

Exclusion Criteria:
• Active brain metastases or leptomeningeal metastases are not allowed
• Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
• Subjects with active, known or suspected autoimmune disease