Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Melanoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

There are three parts to this Phase 1/2 study in subjects with advanced melanoma: Phase 1a will identify the MTD and preliminary safety of combination hydroxychloroquine and nivolumab therapy. Phase 1b will identify the MTD and preliminary safety of hydroxychloroquine administered in conjunction wit...

There are three parts to this Phase 1/2 study in subjects with advanced melanoma: Phase 1a will identify the MTD and preliminary safety of combination hydroxychloroquine and nivolumab therapy. Phase 1b will identify the MTD and preliminary safety of hydroxychloroquine administered in conjunction with nivolumab and ipilimumab therapy Phase 2 will assess the clinical efficacy of combination hydroxychloroquine and nivolumab therapy.

Tracking Information

NCT #
NCT04464759
Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Ravi Amaravadi, MD Abramson Cancer Center of the University of Pennsylvania