RecruitingPhase 1Phase 2NCT04464759

A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma

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


Sponsor

Ravi Amaravadi, MD

Enrollment

94 participants

Start Date

Oct 21, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining the immunotherapy drug nivolumab with hydroxychloroquine (a medication that helps block cancer cells from hiding from the immune system) can improve outcomes for patients with advanced melanoma that has returned or spread. Some combinations also include a second immunotherapy drug, ipilimumab. **You may be eligible if:** - You have advanced (unresectable Stage III or Stage IV) melanoma confirmed by biopsy - You are in reasonably good health (ECOG performance status 0-1) - You have at least one measurable tumor site that has not previously been irradiated - You are able to swallow oral medication - For some groups: you must have previously received immunotherapy; for others, you may be immunotherapy-naive **You may NOT be eligible if:** - You have a serious infection or psychiatric disorder that would prevent safe treatment - You are pregnant or breastfeeding - You have an active autoimmune disease requiring treatment - You have untreated brain metastases - You have significant heart, liver, or kidney problems - You have a known allergy to any of the study medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab

DRUGHydroxychloroquine

Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab

DRUGIpilimumab

Combination of nivolumab, hydroxychloroquine and ipilimumab


Locations(1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT04464759


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