Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm B: 1 cycle low-dose ICI (Nivolumab) followed by Palliative RT 40 Gy/16 fractions/3 weeks @ 2.5 Gy/fraction followed by maintenance ICI with triple oral metronomic therapy
Control In
Sponsors
TMC TATA TRUSTCANCER RESEARCH GRANT TMH AC NO
Eligibility
Inclusion criteria
Inclusion criteria: Histopathologically proven head and neck squamous cell carcinoma locally advanced and not suitable for curative intent treatment or metastatic disease Age 18 years or older ECOG performance status of till 2 Ability to understand and willingness to sign informed consent document form Contraception Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last Nivolumab treatment administration if the risk of conception exists. The effects of Nivolumab on the developing human fetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study she should inform her treating physician immediately. Both men and women of all races and ethnic groups are eligible for this study. Willing and able to comply with all study requirements, including treatment able to be followed up at regular intervals and or nature of required assessments. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: History of previous RT to head and neck region Within 3 weeks of administration of chemotherapeutic agent. Organ transplantation: Prior organ transplantation including allogeneic stem-cell transplantation. Pregnant lady Previous history of ICI administration Severe uncontrolled comorbidities prior documented autoimmune disease History of interstitial lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Timepoint: ;Overall responseTimepoint: at 3 months post RT or at 3 months from start of TMCI;Health related quality of lifeTimepoint: every 4 cycles of nivolumab;Toxicity according to CTCAE V 5.0Timepoint: Every 3 weeks;VAS (Visual Analogue Scale) based scoring for the assessment of pain reliefTimepoint: every 4 cycles of nivolumab | — |
Countries
India
Contacts
Public ContactDr Sambit Swarup Nanda
HBCH & MPMMCC, Varanasi
Outcome results
None listed