CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)
- Conditions
- Metastatic Melanoma
- Interventions
- Registration Number
- NCT04060407
- Lead Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Advanced Melanoma CD24Fc Patients with advanced melanoma. Advanced Melanoma Ipilimumab Patients with advanced melanoma. Advanced Melanoma Nivolumab Patients with advanced melanoma.
- Primary Outcome Measures
Name Time Method Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab 4 weeks The rate of Grade 3 or above treatment-related adverse events (TRAE) at 4 weeks after first dosing of drugs.
- Secondary Outcome Measures
Name Time Method Profile of treatment related adverse events 1 year To tabulate the treatment related adverse events in 1 year
The Objective Response Rate (OPR) 1 year The rate of objective response with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year
The Progression Free Survival (PFS) 1 year The rate of Progression Free Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.
The Overall Survival (OS) 1 year The rate of Overall Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.
Trial Locations
- Locations (1)
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States