Study on Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine for Advanced Melanoma

Sponsor: Ravi Amaravadi, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04464759

Provider View

This clinical trial is testing the safety and effectiveness of combining hydroxychloroquine with nivolumab, and with nivolumab and ipilimumab, in patients with advanced melanoma.

Patient Parameters

Program Overview

The study aims to find out if using hydroxychloroquine together with nivolumab, or with nivolumab and ipilimumab, is safe and can help treat advanced melanoma. Researchers will look at how well the treatment works and how patients respond to it.

Description

This study has three parts:

  • Phase 1a: This part will find the safest dose and check the initial safety of using hydroxychloroquine with nivolumab.
  • Phase 1b: This part will find the safest dose and check the initial safety of using hydroxychloroquine with both nivolumab and ipilimumab.
  • Phase 2: This part will evaluate how effective the combination of hydroxychloroquine and nivolumab is in treating advanced melanoma.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of melanoma that is advanced or cannot be removed by surgery.
  • For Phase 1a: Can have had any previous treatment or be new to treatment.
  • For Phase 2:
    • Cohort 2a: Must have had previous immunotherapy.
    • Cohort 2b: Must not have had anti-PD-1 therapy but can have had other treatments.
  • For Phase 1b: Must have melanoma that did not respond to anti-PD-1 therapy.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have at least one measurable tumor that has not been treated with radiation.
  • Provide a fresh or stored tissue sample for analysis.
  • Women must have a negative pregnancy test before starting treatment.
  • Be able to swallow pills and have no major stomach or bowel issues.
  • Have adequate organ function based on medical tests.

Exclusion Criteria

  • Have a serious infection or medical condition that could make treatment unsafe.
  • Be pregnant or breastfeeding.
  • Have untreated or unstable brain or spinal cord metastases.
  • Have had recent immunotherapy, chemotherapy, or other cancer treatments.
  • Have unresolved side effects from previous cancer treatments, except for hair loss or certain lab values.
  • Be currently responding to immunotherapy.
  • Have had another cancer within the last 3 years, except for certain skin cancers.
  • Have a severe autoimmune disease needing immunosuppressive drugs.
  • Have a history of lung disease not related to previous immunotherapy.
  • Have porphyria or psoriasis unless well-controlled.
  • Have allergies to study drugs or related substances.
  • Be taking certain anticonvulsant drugs or other prohibited medications.
  • Have a history of heart disease or increased cardiovascular risk.

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