drugset / Trial / NCT05968690

Naltrexone and Propranolol Combined With Immunotherapy

NCT05968690

Phase 1 Recruiting 12 enrolled Sarah Weiss
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-09-11
Primary completion
2026-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 4.5 mg Oral
Subject Naltrexone Small molecule 9 mg Oral
Subject Naltrexone Small molecule 25 mg Oral
Subject Propranolol Small molecule 30 mg Oral

Indications