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Naltrexone + Propranolol Combined With Immunotherapy for Melanoma
Phase 1
Recruiting
Led By Sarah Weiss, MD
Research Sponsored by Sarah Weiss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from start of treatment
Awards & highlights
Study Summary
This trial will explore if combining blockers of beta-adrenergic/opioid receptors with immune checkpoint inhibitors could help treat advanced melanoma.
Who is the study for?
Adults with advanced melanoma, either treatment-naïve or previously treated, can join this trial. They must have measurable cancer lesions and normal organ function. Women of childbearing age should use effective contraception or abstain from sex for six months post-treatment; men also need to agree to contraception use. Participants cannot have other active cancers, untreated brain metastases, severe past reactions to anti-PD-1 therapy, certain infections like hepatitis B/C, or be on steroids at enrollment.Check my eligibility
What is being tested?
The trial tests the combination of propranolol (a beta-blocker) and naltrexone (an opioid blocker) with standard immunotherapy in patients with melanoma. It aims to see if stress receptor blockade enhances immune response against tumors. Patients will receive these medications alongside immune checkpoint inhibitors ipilimumab and nivolumab.See study design
What are the potential side effects?
Potential side effects include low blood pressure or slowed heart rate due to propranolol; nausea or headaches from naltrexone; plus typical immunotherapy side effects such as fatigue, skin reactions, inflammation in organs like lungs (pneumonitis), liver issues, hormonal changes and potential autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is at an advanced stage and cannot be surgically removed.
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I am fully active or have some restrictions but can still care for myself.
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I am eligible for treatment with ipilimumab and nivolumab.
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My blood tests show normal organ function.
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I am a male and agree to use contraception for six months after my last treatment dose.
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I can provide a biopsy from my cancer for the study, or discuss alternatives if not possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity of naltrexone in combination with propranolol and ipilimumab plus nivolumab
Recommended phase 2 dose of naltrexone in combination with propranolol and ipilimumab plus nivolumab
Safety as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary outcome measures
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Overall Survival (OS)
Progression-Free Survival (PFS)
Other outcome measures
Exploratory objectives are to assess the impact of propranolol + naltrexone on the anti-tumor immune response through correlative biomarker studies performed on tumor and blood.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4 - Propranolol + Naltrexone 25 mgExperimental Treatment2 Interventions
Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days.
Propranolol will be administered as 30 mg orally twice a day, continuously.
Naltrexone will be administered as 25 mg orally once a day, continuously.
Group II: Cohort 3 - Propranolol + Naltrexone 9 mgExperimental Treatment2 Interventions
Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days.
Propranolol will be administered as 30 mg orally twice a day, continuously.
Naltrexone will be administered as 9 mg orally once a day, continuously.
Group III: Cohort 2 - Propranolol + Naltrexone 4.5 mgExperimental Treatment2 Interventions
Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days.
Propranolol will be administered as 30 mg orally twice a day, continuously.
Naltrexone will be administered as 4.5 mg orally once a day, continuously.
Group IV: Cohort 1 - PropranololExperimental Treatment1 Intervention
Patients will receive intravenous ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 21 days for up to 4 cycles followed by intravenous nivolumab monotherapy 480 mg every 28 days.
Propranolol will be administered as 30 mg orally twice a day, continuously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290
Naltrexone
2005
Completed Phase 4
~2420
Find a Location
Who is running the clinical trial?
Sarah WeissLead Sponsor
Ryan StephensonLead Sponsor
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,220 Total Patients Enrolled
11 Trials studying Melanoma
2,276 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma is at an advanced stage and cannot be surgically removed.I am 18 or older and can understand and sign a consent form.I am fully active or have some restrictions but can still care for myself.I have or haven't had cancer treatment before, but I stopped any small molecule inhibitors two weeks ago.I have no other cancers except for skin cancer.You are expected to live for at least 6 more months.My blood tests show normal organ function.I have at least one tumor that can be measured on a scan.I am eligible for treatment with ipilimumab and nivolumab.I am not using opioids, not opioid-dependent, not pregnant, and not breastfeeding.I am a male and agree to use contraception for six months after my last treatment dose.I am using or willing to use effective birth control or abstain from sex for 6 months after the last dose.I have had targeted radiation therapy before.I have small, symptom-free brain metastases not requiring immediate treatment.I've had severe nerve, heart, or liver side effects from previous anti-PD-1 therapy.My cancer has spread to the lining of my brain and spinal cord.I have lung inflammation that is not caused by an infection.I have received a live vaccine recently.I haven't used any experimental drugs or devices in the last 4 weeks.I have an acute or chronic Hepatitis B or C infection.I am not currently using high-dose steroids for immune-related side effects, or I've been off them for 2 weeks. Low-dose for adrenal issues is okay.I still have side effects from previous treatments that haven't gone away.I am willing to have a tumor biopsy if needed for the study.I can provide a biopsy from my cancer for the study, or discuss alternatives if not possible.I am a woman who can have children and have a negative pregnancy test.I have an autoimmune disease but haven't needed strong medication for it in the last year.I do not have severe asthma, heart issues, uncontrolled diabetes or depression, and I'm not allergic to propranolol.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 - Propranolol + Naltrexone 4.5 mg
- Group 2: Cohort 4 - Propranolol + Naltrexone 25 mg
- Group 3: Cohort 3 - Propranolol + Naltrexone 9 mg
- Group 4: Cohort 1 - Propranolol
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Propranolol from Cohort 1 been passed for federal regulatory approval?
"Our team has assigned Cohort 1 - Propranolol a score of one due to its status as a Phase 1 trial, which indicates that only preliminary studies have been conducted on both safety and efficacy."
Answered by AI
Are there vacancies available for those wishing to partake in this experiment?
"According to clinicaltrials.gov, this particular medical study is not presently enrolling participants. The trial was first posted on September 30th 2023 and last amended on July 18th 2023. Despite the lack of involvement opportunities in this trial, there are still 739 other experiments actively searching for volunteers at the current time."
Answered by AI
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