Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
TATA Trust India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have T3 N1-N3 or T4 HNSCC of the oral cavity who has received immunotherapy in either the palliative or adjuvant treatment setting. 2. Age: Male or female or transgender subjects aged more than or equal to 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 4. Subjects must have normal organ and marrow function as per institute protocols 5. Patients with HIV will be potentially eligible, as long as they have a CD4 count less than 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions. 6. Both men and women of all races and ethnic groups will be eligible for this study. 7. 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. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other investigational agents. 2. Within 2 weeks of administration of a chemotherapeutic agent. 3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses less than or equal to 10 mg per day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis 4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (more than or equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child Pugh B or C. 5. Prior organ transplantation including allogeneic stem-cell transplantation. 6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade more than or equal to 3). 7. Pregnant and lactating women will be excluded from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To identify the molecular genomic alterations in Indian immuno+chemotherapy-treated OSCC patients . 2. To identify the molecular marker alteration profile differentiating the immunotherapy-responder and non-responders. 3.To characterize the immune-cell infiltration dysregulation in the responder and non-responders in response to chemo+immunotherapy 4.To assess quality of life in patients receiving immunotherapy. 5.To assess adverse events as per Common Terminology Criteria for Adverse eventTimepoint: 1.at baseline 2.At 8 weeks, at end of treatment, and during follow-up (up to 12 months). 3.At baseline, 8 weeks, and at follow-up (12 months). 4.At baseline, 2 4 months, and at follow-up (12 months). 5. At each clinical visit during treatment and follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactKavita Nawale
Tata Memorial Centre
Outcome results
None listed