Naltrexone and Propranolol Combined With Immunotherapy
This study tests whether adding two medications (naltrexone and propranolol) to standard immunotherapy can improve how well the immune system fights advanced melanoma. These medications work by blocking stress-related pathways in the body that may interfere with cancer treatment.
Key Objective:The trial is testing whether blocking stress responses with these medications can enhance immunotherapy's effectiveness against advanced melanoma.
Who to Consider:Patients with advanced melanoma who are candidates for immunotherapy and interested in exploring combination treatments may want to consider this trial.
Trial Parameters
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Brief 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.
Eligibility Criteria
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. * 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 o