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Monoclonal Antibody
Propranolol + Pembrolizumab for Skin Cancer
Phase 1 & 2
Recruiting
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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,371 Total Patients Enrolled
Shipra Gandhi, MDPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood tests must show a certain level of white blood cells, red blood cells, and platelets.Your liver function tests should be within a certain range, and a different range applies if you have cancer that has spread to your liver.Your creatinine levels in your blood should be within a certain range.I have not had any other cancer that needed treatment in the last 3 years.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am currently pregnant or nursing.I have been newly diagnosed with advanced melanoma and have not started treatment.You have a disease that can be measured using specific medical guidelines.Your total bilirubin levels should be normal, unless you have Gilbert's syndrome.You have a long-term autoimmune disease.I am currently taking non-selective beta-blockers for my condition.I have brain metastases and received radiation less than 4 weeks ago.I have had immunotherapy for cancer, but not for melanoma, and haven't received interferons or CTLA-4 inhibitors.I have not received a live vaccine in the last 30 days or during the trial.I am currently taking or have taken corticosteroids.I haven't taken steroids or immunosuppressants in the last 14 days.I cannot take beta-blockers due to health reasons.I can swallow and keep down pills.I do not have any other spreading cancers besides non-melanoma.I can provide a previous biopsy sample or am willing to have a new biopsy.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (propranolol hydrochloride, pembrolizumab)
Awards:
This trial has 3 awards, including:- 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 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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