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Monoclonal Antibody

Propranolol + Pembrolizumab for Skin Cancer

Phase 1 & 2

Waitlist Available

Led By Shipra Gandhi, MD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma

Ability to swallow and retain oral medication

Must not have

Contraindications to the use of beta-blockers

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing propranolol hydrochloride in combination with pembrolizumab to see if it is a safe and effective treatment for patients with stage IIIC-IV melanoma.

Who is the study for?

This trial is for adults with stage IIIC-IV melanoma that can't be surgically removed. They must have certain blood counts, understand the study's nature, not be pregnant, agree to use contraception, and have no prior treatments for their melanoma. Exclusions include autoimmune diseases, current beta-blocker use (with exceptions), brain metastases treatment within 4 weeks, recent live vaccines, previous immunotherapy (excluding interferons/CTLA-4 inhibitors), steroid therapy within 14 days before starting the study drug.

What is being tested?

The trial tests how well propranolol hydrochloride enhances immune response when combined with pembrolizumab in treating advanced melanoma. It aims to find the best dose of propranolol and see if this combination works better than pembrolizumab alone by 'taking the brakes off' the immune system to fight cancer.

What are the potential side effects?

Potential side effects may include fatigue, nausea, skin reactions at injection sites from pembrolizumab; and low blood pressure or slow heart rate from propranolol hydrochloride. Other side effects could involve changes in liver enzymes or an increased risk of infections due to immune system alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with advanced melanoma and have not started treatment.

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I can swallow and keep down pills.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take beta-blockers due to health reasons.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am currently pregnant or nursing.

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I have not received a live vaccine in the last 30 days or during the trial.

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I am currently taking or have taken corticosteroids.

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I do not have any other spreading cancers besides non-melanoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicities (DLT) defined as any grade 3 or higher hematological or non-hematological toxicity that is probably or definitely related to treatment according to Common Terminology Criteria for Adverse Events version 4.03 (Phase Ib)

Overall response rate (ORR) per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) version 1.1 (Phase II)

Secondary study objectives

Overall survival (OS) (Phase II)

PFS (Phase II)

Progression free survival (PFS) (Phase II)

Other study objectives

Changes in the levels of biomarkers

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (propranolol hydrochloride, pembrolizumab)Experimental Treatment3 Interventions

Patients receive propranolol hydrochloride PO BID and pembrolizumab IV over 30 minutes of day 1. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Propranolol

FDA approved

0 / 9Eligibility criteria met