A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Last updated on July 2021Recruitment
- 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