Actively Recruiting
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Led by Ravi Amaravadi, MD · Updated on 2026-05-11
94
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
Sponsors
R
Ravi Amaravadi, MD
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological evidence of unresectable Stage III or Stage IV melanoma of any genotype and PD-L1 status
- Phase 1a: any prior treatment status or treatment naive for nivolumab plus hydroxychloroquine
- Phase 2: prior immunotherapy required for Cohort 2a; anti-PD-1 antibody naive for Cohort 2b but may have had other therapies
- Phase 1b: anti-PD-1 refractory for nivolumab, ipilimumab, and hydroxychloroquine
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable disease site by RECIST 1.1 that has not been previously irradiated
- Fresh or archived tissue available for correlative analysis
- Negative pregnancy test within 28 days before dosing for premenopausal women and within 24 hours before treatment
- Able to swallow and retain oral medication with no significant gastrointestinal issues affecting absorption
- Adequate baseline organ function
You will not qualify if you...
- Known serious infections, medical illnesses, or psychiatric disorders that would endanger safe treatment
- Pregnant or breastfeeding women
- Leptomeningeal disease or symptomatic, untreated, or unstable spinal cord compression metastases
- Recent brain metastases treatment less than 2 months ago for whole brain radiation or less than 2 weeks ago for surgery/gamma knife
- Active immunotherapy, chemotherapy, or investigational therapy within 4 weeks before study entry; oral targeted therapy within 2 weeks
- Prior treatment-related toxicities greater than Grade 1, except alopecia and certain lab values
- Phase 2 Cohort B patients with prior immunotherapy
- Patients currently showing partial response to immunotherapy
- History of other malignancies within 3 years except certain skin cancers and indolent malignancies
- Severe autoimmune disease requiring immunosuppressants (except stable adrenal insufficiency on replacement steroids)
- History of interstitial lung disease or chronic pneumonitis unrelated to prior immunotherapy
- Uncontrolled porphyria or psoriasis without specialist monitoring
- Known hypersensitivity to study drugs or related substances
- Use of certain enzyme-inducing anticonvulsants within 4 weeks before treatment
- Use of prohibited medications with risk of drug interactions
- History or evidence of increased cardiovascular risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
L
Lydia Giles, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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