Health Condition 1: D49-D49- Neoplasms of unspecified behavior
Conditions
Interventions
Intervention1: Nivolumab: Inj Nivolumab 40mg in 100ml NS infused via non DHEP codan set over 30 minutes every 3 weeks
Control Intervention1: NIL: NIL
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients unfit for standard cytotoxic chemotherapy due to poor performance status (ECOG PS >2 or organ dysfunction. 2. All patients with a diagnosis of advanced malignancy where nivolumab is approved at standard dose. i. Metastatic Non-Small Cell Lung Cancer ii. Advanced Renal Cell Carcinoma iii. Advanced Squamous Cell Carcinoma of the Head and Neck iv. Advanced Urothelial Carcinoma v. Advanced Esophageal and Gastric Cancer with progression beyond standard fluoropyrimidine- and platinum-based chemotherapy. 3. Patients who have received the full dose of nivolumab but can no longer continue the standard dose of nivolumab due to financial or logistical constraints.
Exclusion criteria
Exclusion criteria: 1. Patients unwilling or incapable of giving informed consent. 2. Patients with prior nivolumab-induced immune-mediated severe adverse reactions. 3. Patients with prior nivolumab induced severe or life-threatening infusion-related reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine objective response rates in patients with advanced cancers receiving Nivolumab 40mg every 3 weeks. 2. To determine clinical response rates in patients with advanced cancers receiving Nivolumab 40mg every 3 weeks. Timepoint: 1. Objective response rate will be evaluated at 12 weeks. 2. Clinical response rate will be evaluated at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine progression-free survival (PFS) in patients with advanced cancers receiving Nivolumab 40mg every 3 weeks. 2. To determine overall survival in patients with advanced cancers receiving Nivolumab 40mg every 3 weeks. 3. To record adverse effects related to Nivolumab.Timepoint: 1. PFS will be calculated from the start of ICI until the date of progression or death due to any cause, or the last follow-up date, whichever is earlier. 2. Overall survival will be calculated from the date of starting ICI to the date of death due to any cause. 3. Adverse events while receiving the immunotherapy will be documented. | — |
Countries
India
Contacts
Public ContactSwaratika Majumdar
Ramaiah Medical College and Hospital, Bangalore
Outcome results
None listed