ow dose Nivolumab in advanced cancers

Phase 2

• Conditions: Health Condition 1: D49-D49- Neoplasms of unspecified behavior

• Registration Number: CTRI/2022/05/042895
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified