An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Head and Neck Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 947
- Locations
- 132
- Primary Endpoint
- Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx \& larynx) that is not amenable to curative therapy.
- •No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
- •Measurable disease detected by imaging exam (CT or MRI).
- •Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
Exclusion Criteria
- •Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
- •No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
- •Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
- •Inadequate hematologic, renal or hepatic function.
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Nivolumab and Ipilimumab
Specified dose on specified days
Intervention: Nivolumab
Nivolumab and Ipilimumab
Specified dose on specified days
Intervention: Ipilimumab
Extreme Regimen
Specified dose on specified days
Intervention: Cetuximab/Erbitux
Extreme Regimen
Specified dose on specified days
Intervention: Cisplatin/Platinol
Extreme Regimen
Specified dose on specified days
Intervention: Carboplatin/Paraplatin
Extreme Regimen
Specified dose on specified days
Intervention: Fluorouracil/Adrucil
Outcomes
Primary Outcomes
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
Time Frame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Overall Survival (OS) in All Randomized Participants
Time Frame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Secondary Outcomes
- Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1(From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months))
- Progression Free Survival (PFS)(From randomization to disease progression or death (Up to approximately 65 months))
- Duration of Objective Response (DOR)(From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months))
- Objective Response Rate (ORR)(From randomization up to approximately 65 months)