RecruitingPhase 1NCT05968690

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


Sponsor

Sarah Weiss

Enrollment

12 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether adding two existing drugs — naltrexone (commonly used for addiction) and propranolol (a beta-blocker used for heart conditions) — to standard immunotherapy improves outcomes in people with advanced melanoma (skin cancer). The standard immunotherapy being used is ipilimumab plus nivolumab. Researchers believe these drugs may enhance the immune system's ability to fight cancer. **You may be eligible if...** - You are 18 years or older with advanced melanoma (unresectable stage III or stage IV) - You are a candidate for standard immunotherapy with ipilimumab and nivolumab - You are physically well enough to carry out normal daily activities (ECOG 0–1) - Your liver, kidney, and blood counts are within acceptable ranges - You have a life expectancy of at least 6 months - You have not taken any small-molecule targeted therapies in the past 2 weeks (prior targeted therapy is allowed) **You may NOT be eligible if...** - You have untreated or actively progressing brain metastases - You have a serious autoimmune disease requiring ongoing treatment with steroids or immune-suppressing drugs - You are pregnant or breastfeeding - You are already enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropranolol

Propranolol will be administered to patients in all cohorts.

DRUGNaltrexone

Naltrexone will be administered to patients in cohorts 2, 3, and 4.


Locations(1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

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NCT05968690


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