Multiple Adjunct Therapies to Improve Immunotherapy Treatment in Patients With Locally Advanced or Metastatic Melanoma or Advanced Hepatocellular Cancer

Conditions

• Advanced Hepatocellular Carcinoma
• Advanced Melanoma
• Locally Advanced Melanoma
• Metastatic Melanoma
• Stage III Hepatocellular Carcinoma AJCC v8
• Stage IV Hepatocellular Carcinoma AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cholecalciferol — DIETARY_SUPPLEMENT
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Desloratadine — DRUG
  Given PO
• Immunotherapy — OTHER
  Given standard of care immunotherapy
• Infusion Procedure — PROCEDURE
  Immunotherapy infusion given prior to 12 PM
• Infusion Procedure — PROCEDURE
  Infusion given per standard of care timing
• Magnesium Sulfate — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Propranolol — DRUG
  Given PO

Study Details

This clinical trial tests the effect of multiple therapies (propranolol, desloratadine, and magnesium and vitamin D supplements) added to primary standard of care immunotherapy (adjunct), as well as adjusting the timing of standard immunotherapy to a morning infusion, in treating patients with melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started to other places in the body (metastatic) or hepatocellular cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Propranolol is a medication used for high blood pressure. Desloratadine is a type of drug that blocks the action of histamines, which can cause fever, itching, sneezing, a runny nose, and watery eyes. Immunotherapy has been approved for multiple kinds of advanced cancers, including melanoma, kidney cancer, non-small cell lung cancer and hepatocellular (liver) cancer. Research suggests that giving propranolol and desloratadine, along with ensuring adequate levels of magnesium and vitamin D, as well as administering immunotherapy infusions in the morning may shrink or stop the spread of advanced cancers better than immunotherapy alone.

Key Dates

First listed

Sep 23, 2026

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Nov 1, 2027

Completion

Nov 1, 2028

Study Design

Enrollment

46 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Adjunct interventions)
  Patients receive standard of care PD-1/PD-L1-containing immunotherapy infusion, starting before 12 PM, desloratadine PO QD, propranolol PO BID, magnesium IV if magnesium level is below 1.9, and vitamin D PO QD if vitamin D level is below 30. Additional IV or oral magnesium and vitamin D supplementation may be administered at the investigator's discretion per standard of care. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
• Active Comparator: Arm B (Standard interventions)
  Patients receive standard of care PD-1/PD-L1-containing immunotherapy, starting at standard of care time. Magnesium and vitamin D levels are checked with any supplementation per investigator discretion and institutional practice, without a prespecified goal level. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.

Primary Outcome Measure

Change in interleukin-8 levels [ Time Frame: From baseline to 12 weeks ]

Locations (1)

Find similar trials in Los Angeles, CA

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