Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Immune check inhibitor drugs along with Vitamin D, Magnesium and Desloratidine: Immune Check Inhibitor administration: Drugs, including nivolumab, pembrolizumab, atezolizumab, and durva
Sponsors
EMORY UNIVERSITYMorningside Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (more than and equal to 18 years) with histologically or cytologically confirmed advanced and metastatic: Non-small cell lung cancer (NSCLC) 2. Renal cell carcinoma (RCC) 3. Head and neck cancers 4. Planned to begin standard-of-care PD-1 and PD-L1 ICI (monotherapy or appropriate combination) in palliative setting 5. ECOG performance status of 0,1 or 2 6. Standard laboratory criteria for adequate organ and marrow functions to administer ICIs 7. eGFR of more than and equal to 30mlper min, 8. LFT with Bilirubin less than 1.5 times ULN, AST/ALT less than 2.5 times ULN, ALP less than 5 times ULN. 9. Adequate bone marrow function like Hb more than 8 g per dl, Platelet more than equal to 100,000 per mm3 and ANC more than 1500 per mm3 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior systemic anti-cancer therapy (including immunotherapy) in the last 6 months. ( If ICI and Chemotherapy was used in adjuvant and neoadjuvant setting earlier, at least 6 months should have passed since the last dose) 2. Concomitant or prior use of immunosuppressive medication within 28 days before registration, with the exceptions of: intranasal and inhaled corticosteroids systemic corticosteroids less than 10 mg per day of prednisone, or a dose equivalent corticosteroid, premedication for chemotherapy Active, known, or suspected autoimmune disease (except type I diabetes mellitus, hypothyroidism, skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment, and conditions not expected to recur in the absence of an external trigger) Patients already receiving vitamin D or magnesium supplementation Patients receiving any other anti-histamine drug for some pre-existing condition Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia); Atrioventricular (AV) block of any degree unless being treated with cardiac pacemakers; Bradycardia less than 40 per min at steady state Contraindications or allergies to any study intervention Untreated and symptomatic brain metastasis requiring steroids more than 10 mg prednisolone equivalent Pregnancy or lactation Restriction: Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if combined morning ICI infusion plus desloratadine, magnesium, and vitamin D supplementation improves 6-month PFS per RECIST v1.1 compared to standard-of-care PD-1/PD-L1 therapy.Timepoint: To evaluate if combined morning ICI infusion plus desloratadine, magnesium, and vitamin D supplementation improves 6-month PFS per RECIST v1.1 compared to standard-of-care PD-1/PD-L1 therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess objective response rate, safety/adverse event profile, & immuno-biomarker correlations (NLR, LDH, CRP, & monocyte counts). Biomarker correlation of response: o Peripheral blood T cell kinetics using multicolour flow cytometry (FCM) o Peripheral blood Myeloid-derived suppressor cells (MDSCs) kinetics using multicolour flow cytometry Timepoint: To assess objective response rate, safety/adverse event profile, & immuno-biomarker correlations (NLR, LDH, CRP, & monocyte counts) AT BASELINE, 03 MONTHS AND 6 MONTHS Biomarker correlation of response: Peripheral blood T cell kinetics using multicolour flow cytometry (FCM) Peripheral blood Myeloid-derived suppressor cells (MDSCs) kinetics using multicolour flow cytometry AT BASELINE AND 03 WEEKS | — |
Countries
India
Contacts
Public ContactDR PRABHAT SINGH MALIK
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed