Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Metronomic chemotherapy with low-dose Nivolumab.: Patients in Arm B will receive metronomic chemotherapy with low-dose Nivolumab. The patients post 2 cycles will be seen in a joint clin
Sponsors
Cancer Research and Statistics Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have T3N2-N3 or T4 HNSCC in the oral cavity. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 3. Subjects must have normal organ and marrow function as per institute protocols. 4. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have an absence of active AIDS-defining conditions. 5. Both men and women of all races and ethnic groups are eligible for this study. 6. 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. 7. 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 = 10 mg/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, Steroids 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 ( 5. Prior organ transplantation including allogeneic stem-cell transplantation. 6. Active infection requiring systemic therapy. 7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3). 8. Pregnant and lactating women are excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS)Timepoint: DFS will be the duration in days from the date of randomization to the date of progression or death whichever was earlier. DFS cannot be calculated at a specific time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) and adverse event rate (ADR)Timepoint: 1. OS will be the duration in years from date of randomization to date of death. In patients who were alive till the last follow up this duration will be calculated from the date of randomization to the date of the last follow-up. 2. ADR will be calculated as a percentage of patients having adverse events. CTCAE version 5.0 will be used. The endpoints cannot be calculated at a specific time point. Kindly refer to the definitions. | — |
Countries
India
Contacts
Public ContactDr Vijay Patil
Tata Memorial Hospital
Outcome results
None listed