Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Low dose Nivolumab: 20 mg IV in 100 ml NS over 1hr (IV line with low-protein binding 0.2 or 0.22 micron in-line filter) every 2 week
Control Intervention1: Paclitaxel or Docetaxel
The
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have recurrent-relapsed or progressed solid tumor cancer after at least one line of systemic treatment, and are planned for palliative intent systemic therapy ( In case of failure within 6 months of administration of curative treatment, the chemotherapy received during this treatment will be considered as �rst line). Sites (These are the sites were nivolumab is the standard of care treatment) applicable are Lung cancer1. Head and neck cancer 2. Urothelial cancer 3. Triple negative breast cancer 4. Esophageal cancer 5. Any solid tumor with microsatellite instability-high (MSI-H) or mismatch repair de�cient (dMMR) status 6. 2. Age: Male or female subjects aged >= 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 4. Subjects must have normal organ and marrow function as de�ned below: a. Hematologic: Absolute neutrophil count (ANC) >= 1.5 � 109/L, platelet count >= 100 � 109/L, and hemoglobin >= 8 g/dL (may have been transfused). b. Hepatic: Total bilirubin level = 30 mL/min according to the Cockcroft-Gault formula. 5. Presence of at least one measurable lesion as de�ned by RECIST version 1.1. 6. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active anti-retroviral therapy), and have absence of active AIDS de�ning conditions. 7. Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential. 8. Contraception: Highly e�ective 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 e�ects 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. 9. Both men and women of all races and ethnic groups are eligible for this study. 10. 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. 11. 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 3 weeks of administration of chemotherapeutic agent. 3. IMMUNOSUPPRESSANTS: 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 4. AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. 5. ORGAN TRANSPLANTATION: Prior organ transplantation including allogeneic stem-cell transplantation. 6. INFECTIONS: Active infection requiring systemic therapy. 7. HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive). 8. VACCINATION: Vaccination within 4 weeks of the �rst dose of Nivolumab and while on study is prohibited except for administration of inactivated vaccines. 9. HYPERSENSITIVITY TO STUDY DRUG: 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). 10. CARDIOVASCULAR DISEASE: Clinically signi�cant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke ( = New York Heart Association Classi�cation Class II), or serious cardiac arrhythmia requiring medication. 11. OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI-CTCAE v4.03 Grade > 1); however, alopecia, sensory neuropathy Grade 12. Other severe acute or chronic medical conditions including immune colitis, in�ammatory bowel disease, immune pneumonitis, pulmonary �brosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. 13. Pregnant women are excluded from this study. Based on its mechanism of action. Nivolumab can cause foetal harm when administered to a pregnant woman. Therefore, potential risks of administering Nivolumab during pregnancy include increased rates of abortion or stillbirth. Advise females of reproductive potential to use e�ective contraception during treatment and for at least one month after the last dose of Nivolumab. 14. Lactating females: There is no information regarding the presence of Nivolumab in human milk, the e�ects on the breastfed infant, or the e�ects o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Timepoint: at 5th year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Objective response (Complete or partial response) to treatment 2.Disease control rate 3.Progression free survival 4.Toxicity and Quality of Life (QOL) 5.Cost eï¬?ective analysisTimepoint: 1.Objective response (Complete or partial response) to treatment -2 months 2.Disease control rate-2 months 3.Progression free survival- 5 year 4.Toxicity and Quality of Life (QOL)- 8 week 5.Cost eï¬?ective analysis- 5 year | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed