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CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI) — CINDI  

Metastatic Melanoma Clinical Trial

Official title:
Phase Ib/II Study Combining CD24Fc With Checkpoint Inhibitors for Patients With Metastatic Melanoma

Clinical Trial Summary

This is a phase Ib/II clinical trial to test safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to decrease irAE, with built-in interim analyses, and safety and response stopping rules.

Clinical Trial Description

This is a phase 1b/II clinical trial using a fixed recommended phase 2 dose (RP2D) of CD24Fc to explore the safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to reduce the toxicity of immunotherapy combination, in patients who are naïve to anti-PD1/L1 based checkpoint inhibitors. The dosing of nivolumab and ipilimumab will be fixed at FDA approved levels for each indication. Dosing of the drugs will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion is met. Patients who complete 12 months on study treatment and demonstrate clinical benefit with manageable toxicity will be given the opportunity to continue treatment for another 12 months upon agreement between investigator and drug manufacturers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04060407
Study type Interventional
Source OncoImmune, Inc.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date June 15, 2021
Completion date December 30, 2023
View Details
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