Sarah Weiss
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.
This is an open-label, single institution, phase I clinical trial to investigate the safety, tolerability, and preliminary efficacy of dose-escalated naltrexone (NTX) in combination with propranolol (PRO), ipilimumab (IPI), and nivolumab (NIVO) in patients with advanced melanoma.
Inclusion Criteria: * 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. * Presenc…
Propranolol will be administered to patients in all cohorts.
Naltrexone will be administered to patients in cohorts 2, 3, and 4.
Arctuva estimate
Verify or correct the compensation shown for this listing.