Naltrexone and Propranolol Combined With Immunotherapy
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Sarah Weiss
You may qualify if…
- ✓ Age of 18 years or older and able to understand and sign the informed consent form.
- ✓ Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma.
- ✓ Candidate for standard of care therapy with ipilimumab 3 mg/kg + nivolumab 1 mg/kg.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- ✓ Treatment-naïve or has received any number of prior lines of therapy. Prior targeted therapy is allowed, but small molecule inhibitors must be discontinued within two weeks before starting the study.
- ✓ Life expectancy of at least 6 months.
- ✓ Presence of at least one accessible site of disease to provide an on-study biopsy for tumor tissue. The biopsy may be waived after discussion with the Principal Investigator (PI) if it is deemed unfeasible. The site may be a target lesion as long as it will not be rendered unmeasurable by the biopsy procedure.
- ✓ Willingness to undergo tumor biopsy (if archival tumor is not available) prior to initiation of therapy and while on the study.
You may not qualify if…
- ✕ Presence of untreated brain metastases, unless discussed with the Principal Investigator (PI) and meet specific criteria for inclusion (treatment-naïve patients with brain metastases \<10 mm, asymptomatic, without significant edema, hemorrhage, shift, or requirement for steroids or anti-seizure medications, and not in eloquent areas). These patients may potentially forego initial local treatment of the brain metastases and have them reassessed after consultation with the Neurosurgery and Radiation Oncology teams.
- ✕ Use of corticosteroids to control immune-related adverse events at enrollment. Participants who previously required corticosteroids for symptom control must be off steroids for at least two weeks. Low-dose steroid use (=10 mg of prednisone or equivalent) as corticosteroid replacement therapy for primary or secondary adrenal insufficiency is allowed.
- ✕ Failure to recover (i.e., Grade 1 or at baseline) from adverse events due to prior treatment.
- ✕ History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1 therapy.
- ✕ Presence of leptomeningeal disease.
- ✕ Active autoimmune disease unrelated to the use of immune checkpoint inhibitors that has required systemic treatment in the past year (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- ✕ Contraindications to the use of propranolol, including:
- ✕ 1. Cardiogenic shock.
Where it's recruiting
New Brunswick
Source: ClinicalTrials.gov · NCT05968690 · last updated 2025-09-18