drugset / Trial / NCT04464759

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

NCT04464759

Phase 1/2 Active not recruiting 41 enrolled Ravi Amaravadi, MD Bristol-Myers Squibb · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-10-21
Primary completion
2026-07-31
Completion
2027-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 400 mg Oral
Subject Hydroxychloroquine Small molecule 600 mg Oral
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous

Indications