Naltrexone and Propranolol Combined With Immunotherapy

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Sarah Weiss
Study ID
NCT05968690
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Propranolol — DRUG
    Propranolol will be administered to patients in all cohorts.
  • Naltrexone — DRUG
    Naltrexone will be administered to patients in cohorts 2, 3, and 4.

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Propranolol
    Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days. Propranolol will be administered as 30 mg orally twice a day, continuously.
  • Experimental: Cohort 2 - Propranolol + Naltrexone 4.5 mg
    Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days. Propranolol will be administered as 30 mg orally twice a day, continuously. Naltrexone will be administered as 4.5 mg orally once a day, continuously.
  • Experimental: Cohort 3 - Propranolol + Naltrexone 9 mg
    Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days. Propranolol will be administered as 30 mg orally twice a day, continuously. Naltrexone will be administered as 9 mg orally once a day, continuously.
  • Experimental: Cohort 4 - Propranolol + Naltrexone 25 mg
    Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days. Propranolol will be administered as 30 mg orally twice a day, continuously. Naltrexone will be administered as 25 mg orally once a day, continuously.

Primary Outcome Measure

Safety as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: initial 28 days of treatment and then for up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Sarah Weiss, MD
[email protected]
732-235-2465

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By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJ

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