EUCTR2017-004936-13-GR
Active, not recruiting
Phase 1
A phase III randomized trial of post-operative adjuvant nivolumab and concomitant chemo-radiotherapy in high-risk patients with resected squamous cell carcinoma of head and neck (SCCHN) - NIVO POST-OP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GORTEC
- Enrollment
- 680
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \> 18 and \< 75 years
- •2\. Performance Status (PS) ECOG 0\-1 (Appendix 2\)
- •3\. Written informed consent
- •4\. Recording of alcohol consumption and smoking history
- •5\. Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- •6\. Squamous cell carcinoma of the head and neck treated by primary surgery
- •7\. Histopathological classification: pStage III or IV. However, Oropharyngeal Cancer pStage II p16 positive with pT3N1 or pT4N1 and tobacco consumption \=20 packs/year are eligible. (American Joint Committee on Cancer 8th edition) 38
- •8\. Subject must have complete macroscopic resection.
- •9\. Subject must be free of disease
- •10\. Recovery from the surgical procedure allowing for cisplatin\-Radiotherapy
Exclusion Criteria
- •1\. Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- •2\. Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- •3\. Metastatic disease
- •4\. Incomplete macroscopic resection (R2\), as stated in the surgical report
- •5\. Known active viral infection (Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV, active autoimmune disease and/or active immunodeficiency or ongoing immunosuppressive therapy
- •6\. Active central nervous system disease
- •7\. Interstitial lung disease
- •8\. Active infection
- •9\. Any prior treatment for the current head and neck cancer other than primary surgery. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior RT, or use of any investigational agent
- •10\. Concurrent treatment with any other systemic anti\-cancer therapy that is not specified in the protocol
Outcomes
Primary Outcomes
Not specified
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