Study on Propranolol and Pembrolizumab for Treating Advanced Melanoma That Cannot Be Removed by Surgery

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03384836

Provider View

This clinical trial is testing a combination of propranolol and pembrolizumab to see if it can effectively treat advanced melanoma that cannot be surgically removed. The study aims to find the best dose and evaluate how well the treatment works.

Patient Parameters

Program Overview

This study is exploring the use of propranolol, a medication that can enhance immune responses, together with pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells. The goal is to determine if this combination can effectively treat patients with advanced melanoma that cannot be removed by surgery. The trial will assess the side effects and the best dose of propranolol when used with pembrolizumab, as well as how well the treatment works in shrinking tumors and improving patient outcomes.

Description

The study is divided into two phases. In the first phase, researchers will determine the safest dose of propranolol when combined with a fixed dose of pembrolizumab. In the second phase, they will evaluate how well this combination works in treating melanoma by measuring the overall response rate, progression-free survival, and overall survival.

Participants will take propranolol orally twice a day and receive pembrolizumab through an IV infusion every three weeks for up to two years, as long as the cancer does not progress and side effects are manageable. After completing the treatment, participants will have follow-up visits at 30 days, every three months for six months, and then every six months thereafter.

The study will also look at various biomarkers to see if they can predict how well the treatment works. These include certain immune cells, stress levels, and other biological markers.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with advanced melanoma (stage IIIC or IV) that cannot be removed by surgery.
  • In good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must provide a previous tumor sample or agree to a new biopsy before starting treatment.
  • Have measurable cancer according to specific criteria.
  • Able to swallow pills.
  • Meet specific blood test requirements, including adequate levels of neutrophils, hemoglobin, and platelets.
  • Liver and kidney function within specified limits.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
  • Must understand the study and sign a consent form.

Exclusion Criteria

  • Have received previous immunotherapy for any cancer other than melanoma.
  • Have chronic autoimmune diseases.
  • Currently taking non-selective beta-blockers, unless willing to switch to propranolol.
  • Have untreated or symptomatic brain metastases.
  • Have had other invasive cancers within the past three years that required treatment.
  • Have uncontrolled illnesses, such as heart failure or infections.
  • Pregnant or breastfeeding women.
  • Unable or unwilling to follow study requirements.
  • Have other active cancers.
  • Have conditions that prevent the use of beta-blockers, such as severe asthma or uncontrolled diabetes.
  • Currently taking or have recently taken systemic steroids or immunosuppressive drugs.
  • Have received a live vaccine within 30 days before starting the study.

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