drugset / Trial / NCT05968690
Naltrexone and Propranolol Combined With Immunotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |