Locally advanced squamous cell carcinoma of the oral cavity MedDRA version: 21.0 Level: PT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo
Product Name: Opdivo
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nivolumab
CAS Number: 946414-94-4
Concentration unit: mg/ml milligram(s)/millili
Sponsors
The Clatterbridge Cancer Centre NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed, written informed consent 2. Subjects must be willing and able to comply with scheduled visits and procedures 3. Histologically confirmed squamous cell carcinoma of the oral cavity, (oral tongue (anterior 2/3), gingiva/alveolus, floor of mouth, buccal sulcus, retromolar trigone, and hard palate as defined by ICD-10 codes) 4. Subjects willing to have a fresh biopsy performed, or archival tissue available from diagnostic biopsy meeting requirements set out in laboratory manual. 5. Clinically and/or radiologically staged as T1-4 N1-3 or any T3-4 N0 (unless T4 on the basis of bone invasion only). Staging based upon the AJCC/UICC TNM 8th Edition. 6. Surgery planned as primary treatment modality with patients fit for major resection ± reconstruction surgical procedure. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. 18 years or over at time of provision of consent for trial inclusion. 9. Screening laboratory values must meet the following criteria WBC ? 2000/µL Neutrophils ? 1500/uL Platelets ? 100x103/uL Hemoglobin ? 9.0 g/dL Serum creatinine ?1.5 x ULN or calculated creatinine clearance > 40 mL/min (using the Cockcroft-Gault formula) AST ? 3.0 x ULN ALT ? 3.0 x ULN Total Bilirubin ? 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Tumours staged as T4 on the basis of bone invasion only and in the absence of nodal metastases. 2. Distant metastases detected, or suspected on imaging 3. Unfit for chemoradiotherapy, due to comorbidity. 4. Previous malignancy requiring treatment within the last 3 years (with the exception of non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, oesophageal endometrial, cervical/dysplasia, melanoma, or breast). Prior head and neck cancer within the last three years is allowed if the tumour was treated with surgery only, and did not require radiotherapy. 5. Prior head and neck radiotherapy 6. On immunosuppressive medication (including steroids at dose equivalent to prednisolone >10mg/day unless used as replacement therapy). 7. Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, lichen planus or other conditions not expected to recur in the absence of an external trigger are permitted to enrol. 8. Known human immunodeficiency virus (HIV) or viral hepatitis infection. 9. Women who are pregnant or breastfeeding 10. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether Nivolumab in addition to standard therapy (Surgury followed by radiotherapy or radiotherapy with chemotherapy)leads to a reduction of disease recurrence. Feasibility of recruitment into both cohorts;Secondary Objective: To determine; Overall survival Toxicity and safety. Quality of Life To determine the following surgical complications; Infection rate length of hospital admission Free flap faliure Perioperative mortality ;Primary end point(s): •1 year Disease Free Survival defined as disease recurrence or death at 12 months following surgery •Feasibility of the study to recruit to both cohorts of the study ;Timepoint(s) of evaluation of this end point: The endpoint is disease recurrence at 12 months measured as a 1 for patients who have disease recurrence (or death by any cause) and 0 for those that do not. Feasibility will predominantly be assessed as using the recruitment rate as the endpoint of interest measured as the number of patients/site/month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease free survival measures as the time from surgery until disease recurrence or death by any cause. •Overall survival measured as the time from surgery to death by any cause •Toxicity measured based on CTCAE (Version 4) definitions •Surgical complications; a. Infection rate measured using Clavien Dindo classifications b. length of hospital admission measured in days c. Free flap failure measured as a binary covariate d. Perioperative (30-day) mortality) measured as a binary covariate •Quality of Life Questionnaire–Core 30 module (QLQ-C30) and the head-and-neck–specific module (QLQ-H&N35) | — |
Countries
United Kingdom
Contacts
Public ContactCRUK Liverpool Cancer Trials Unit
University of Liverpool
Outcome results
None listed