OncoMatch

OncoMatch/Clinical Trials/NCT05968690

Naltrexone and Propranolol Combined With Immunotherapy

Is NCT05968690 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Propranolol and Naltrexone for advanced melanoma.

Phase 1RecruitingSarah WeissNCT05968690Data as of May 2026

Treatment: Propranolol · NaltrexoneVarious 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 0 prior lines

Cannot have received: investigational agent

Receipt of any other investigational agents or participation in a study of an investigational agent or use of an investigational device within four weeks of the first dose of treatment.

Lab requirements

Blood counts

ANC >1500/mcL; platelets >100,000/mcL; hemoglobin >9 g/dL; albumin >2.5 mg/dL

Liver function

AST and ALT <2.5x ULN; serum total bilirubin <1.5x ULN or direct bilirubin < ULN for subjects with total bilirubin >1.5x ULN.

Normal organ function, defined as: 1. Absolute neutrophil count (ANC) >1500/mcL 2. Platelets >100,000/mcL 3. Hemoglobin (Hb) >9 g/dL 4. Albumin >2.5 mg/dL 5. AST and ALT <2.5x ULN 6. Serum total bilirubin <1.5x ULN or direct bilirubin < ULN for subjects with total bilirubin >1.5x ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey

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