NCT05968690

Naltrexone and Propranolol Combined With Immunotherapy

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sarah Weiss · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Propranolol	Propranolol will be administered to patients in all cohorts.
DRUG	Naltrexone	Naltrexone will be administered to patients in cohorts 2, 3, and 4.

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2023-08-01
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study