Actively Recruiting
Naltrexone and Propranolol Combined With Immunotherapy
Led by Sarah Weiss · Updated on 2025-09-18
12
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Various forms of stress can promote cancer development and growth and negatively impact the immune system's response to tumors. Beta-adrenergic and opioid receptors co-exist in many cells including immune cells and are integral components of the body's response to stress. Pre-clinical studies have demonstrated that dual blockade of these receptors can decrease tumor growth and modulate the anti-tumor immune response. This clinical trial investigates the safety and potential therapeutic benefits of combining a beta-adrenergic blocker (propranolol) and an opioid receptor antagonist (naltrexone) with immune checkpoint inhibitors in patients with advanced melanoma.
CONDITIONS
Official Title
Naltrexone and Propranolol Combined With Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to consent
- Histologically confirmed unresectable stage III or IV melanoma
- Eligible for standard ipilimumab 3 mg/kg and nivolumab 1 mg/kg therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Treatment-na�efve or any number of prior therapies; prior targeted therapy allowed if stopped at least 2 weeks before study
- Life expectancy of at least 6 months
- At least one accessible tumor site for biopsy or waiver by investigator
- Willing to undergo tumor biopsy before and during study if archival tissue unavailable
- Willing to provide archival tissue for research if available
- Normal organ function including specified blood counts and liver tests
- Negative pregnancy test and use of effective contraception for females of childbearing potential
- Adequate contraception for males during and 6 months after study
- At least one measurable lesion by CT or MRI per RECIST v1.1
- Prior focal radiotherapy allowed
You will not qualify if you...
- Untreated brain metastases except selected small, asymptomatic cases after specialist consultation
- Use of corticosteroids for immune-related adverse events at enrollment; must be off steroids for at least 2 weeks if prior use
- Incomplete recovery from prior treatment adverse events
- History of severe neurologic, cardiac, or liver toxicity from prior anti-PD-1 therapy
- Presence of leptomeningeal disease
- Active autoimmune disease requiring systemic treatment in past year
- Contraindications to propranolol including cardiogenic shock, significant bradycardia, severe asthma, hypersensitivity, need for other beta-blockers, uncontrolled diabetes or depression, recent unstable angina or heart attack
- Contraindications to naltrexone for cohorts 2-4 including current or anticipated opioid use, opioid dependence, acute opioid withdrawal, or sensitivity to naltrexone
- Pregnancy or breastfeeding
- Participation in other investigational studies within 4 weeks
- Concurrent conditions or prior illnesses posing unacceptable risk or confounding data
- Other active malignancies except certain skin cancers
- Active pneumonitis
- Acute or chronic hepatitis B or C infection
- Receipt of live vaccines recently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
Research Team
S
Sarah Weiss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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