Locally advanced, resectable HNSCC (head and neck squamous cell carcinoma) MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: OPDIVO (100 mg/10 ml)
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: YERVOY
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven SCC of the oropharynx, oral cavity, hypopharyngx, and larynx • clinical stage III-IVB (T1, N2-3; T2, N2-3; T3, N0-3; T4a, N0-3) • oropharyngeal cancer HPV-negative • Primary tumor and neck metastasis must be resectable • Written and signed informed consent • ECOG PS 0/1 • Age = 18 • Curative treatment intent • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils =1500/µL, platelets = 100 x103/µL, hemoglobin > 9.5 g/dL • Adequate liver function: Bilirubin =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis • Prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA and other antibodies targeting checkpoint pathways • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening • Previous treatment with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck • Subjects with a condition requiring systematic treatment either corticosteroids or other immunsuppressive medications within 4 weeks of randomization • Prior invasive malignancy except controlled skin cancer or carcinoma in situ of cervix • Unknown primary (CUP), nasopharyngeal or salivary gland cancer • Metastatic disease • Allergies and Adverse Drug Reaction concerning study drug components and any monoclonal antibodies • Patients with positive hepatitis B or hepatitis C indicating acute or chronic infection • Patients with known human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) • Serious co-morbidity, e.g. high-grade carotis stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C • Hemoglobin level <9.5g/dl within 10 days before randomization • Pregnancy or lactation • Women of child-bearing potential with unclear contraception • Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol • Patients institutionalized by official means or court order • Deficient dental preservation status or not accomplished wound healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety in terms of disease free survival (DFS) at 3 years of nivolumab alone or in combination with ipilimumab as adjuvant immunotherapy after adjuvant radio(chemo)therapy in locally advanced resected HNSCC. ;Secondary Objective: • Local regional control (LRC) • Distant metastasis free survival (DMFS) • Overall survival (OS) • acute toxicity and late morbidity • Quality of life (QoL) • Survival depending on PD-L1 Status • Comparison of nivolumab alone group vs control and nivolumab & ipilimumab group vs control in terms of DFS ;Primary end point(s): Disease free survival (DFS): Defined as time from randomization to date of first observed either histologically proven recurrence (local, locoregional or distant), or death from any cause whatever occurs first. Second malignancy will not be counted as event in the DFS analysis. ;Timepoint(s) of evaluation of this end point: The time of reaching the primary endpoint DFS (and secondary survival endpoints LRC, DMFS, OS) will be censored at study end for event-free patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Local regional control (LRC) • Distant metastasis free survival (DMFS) • Overall survival (OS) • Therapy-associated toxicity • Quality of Life (QoL) ;Timepoint(s) of evaluation of this end point: At study end or: Therapy-associated toxicity: During therapy (acute) and 1 and 2 years after randomization Quality of Life (QoL) at 1 and 2 years after randomization | — |
Countries
Germany
Contacts
Public ContactStudy Coordinator
University Medical Center Hamburg-Eppendorf, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Outcome results
None listed