Spots Global Cancer Trial Database for A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
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Trial Identification
Brief Title: A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Official Title: LIMIT Melanoma: (Lysosomal Inhibition + Melanoma ImmunoTherapy) A Phase 1/2 Open Label Trial of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Patients With Advanced Melanoma
Study ID: NCT04464759
Conditions
Study Description
Brief Summary: This study will evaluate the safety, tolerability and efficacy (objective response rate) of using hydroxychloroquine (HCQ) in combination with nivolumab and ipilimumab or with nivolumab alone in subjects with advanced/metastatic melanoma.
Detailed 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 with nivolumab and ipilimumab therapy Phase 2 will assess the clinical efficacy of combination hydroxychloroquine and nivolumab therapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: Ravi Amaravadi, MD
Affiliation: Abramson Cancer Center at Penn Medicine
Role: PRINCIPAL_INVESTIGATOR
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