A Phase I Study to Evaluate the Safety of Naltrexone and Propranolol in Combination With Standard of Care Ipilimumab and Nivolumab in Patients With Advanced Melanoma
Sarah Weiss
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPropranolol
Propranolol will be administered to patients in all cohorts.
- DrugNaltrexone
Naltrexone will be administered to patients in cohorts 2, 3, and 4.
Location
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey