CTRI/2022/05/042895
Not yet recruiting
Phase 2
A phase 2 single arm study evaluating the safety and efficacy of fixed low dose nivolumab in advanced malignancy. - NI
I0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- I
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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