Health Condition 1: C060- Malignant neoplasm of cheek mucosa
Conditions
Interventions
Intervention1: Neoadjuvant Chemotherapy + LDI: Nivolumab 40mg every 2 weeks administered via intravenous (IV) infusion over 30 ±5 minutes for a total of 4 + Standard NACT with TPF (Docetaxel +Cisplat
Sponsors
HCG Institutional research Fund
Eligibility
Inclusion criteria
Inclusion criteria: Subject age 18 to 70 yrs Either male or female Histologically or cytologically documented squamous cell carcinoma of Buccal mucosa Locally advanced (T3-T4,N2-N3, M0) (Stage IVa, IVb) subject if fit to take TPF neoadjuvant chemotherapy
Exclusion criteria
Exclusion criteria: 1. Subjects with Head and neck cancer with Squamous cell carcinoma other than Buccal mucosa or Buccal mucosa with any distant metastatic disease 2. Non squamous cell carcinoma HPE or Salivary gland tumors or Nasopharyngeal tumors 3. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti- HCV at Screening 4. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening 5. Other active malignancy requiring concurrent intervention. 6. Subject with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to screening AND no additional therapy is required or anticipated to be required during the study period. 7. Subject with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Corticosteroids with minimal systemic absorption and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 8. Subject with active, known or suspected autoimmune disease. Subject with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 9. Prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents 10. Prior radiotherapy or radiosurgery received within 2 weeks prior to screening. 11. Prior treatment with Nivolumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CD-137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) 12. Subject with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity 13. Recent cardiac illness myocardial infarction within 6 months 14. Subject not recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment. 15. History of severe hypersensitivity reactions to other monoclonal antibodies. 16. Allergy or intolerance (unacceptable adverse event) to study drug components, or Polysorbate-80-containing infusions 17. Ongoing or planned administration of anti-cancer therapies other than those specified in this study or use of strong CYP3A4 inhibitors. 18. Have received treatment with any other investigational drug in the last 30 days before study entry, or within less than five half-lives after receiving the previous investigational drug. 19. Receipt of IV antibiotics for infection within 14 days of randomization 20. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment. 21. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response RateTimepoint: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response Disease Free Survival Overall Survival Safety Quality of lifeTimepoint: Disease Free Survival at 6,12,18,24 months Overall Survival at 6,12,18,24 months | — |
Countries
India
Contacts
Public ContactDr Harish Venkataravanappa Reddy
Health Care global enterprisers Ltd
Outcome results
None listed