xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968690</url>
    </required_header>
    <id_info>
      <org_study_id>092302</org_study_id>
      <secondary_id>Pro2023001214</secondary_id>
      <nct_id>NCT05968690</nct_id>
    </id_info>
    <brief_title>Naltrexone and Propranolol Combined With Immunotherapy</brief_title>
    <official_title>A Phase I Study to Evaluate the Safety of Naltrexone and Propranolol in Combination With Standard of Care Ipilimumab and Nivolumab in Patients With Advanced Melanoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ryan Stephenson</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Various forms of stress can promote cancer development and growth and negatively impact the&#xD;
        immune system's response to tumors. Beta-adrenergic and opioid receptors co-exist in many&#xD;
        cells including immune cells and are integral components of the body's response to stress.&#xD;
        Pre-clinical studies have demonstrated that dual blockade of these receptors can decrease&#xD;
        tumor growth and modulate the anti-tumor immune response. This clinical trial investigates&#xD;
        the safety and potential therapeutic benefits of combining a beta-adrenergic blocker&#xD;
        (propranolol) and an opioid receptor antagonist (naltrexone) with immune checkpoint&#xD;
        inhibitors in patients with advanced melanoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, single institution, phase I clinical trial to investigate the safety,&#xD;
        tolerability, and preliminary efficacy of dose-escalated naltrexone (NTX) in combination with&#xD;
        propranolol (PRO), ipilimumab (IPI), and nivolumab (NIVO) in patients with advanced melanoma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>This is an open-label, single institution, phase I study with a 3+3 design of dose escalated naltrexone in combination with propranolol 30 mg bid and ipilimumab 3 mg/kg plus nivolumab 1 mg/kg q3wk for up to 4 doses followed by NIVO monotherapy q4wk in participants with advanced melanoma.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0</measure>
      <time_frame>initial 28 days of treatment and then for up to 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Dose-limiting toxicity of naltrexone in combination with propranolol and ipilimumab plus nivolumab</measure>
      <time_frame>initial 28 days of treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended phase 2 dose of naltrexone in combination with propranolol and ipilimumab plus nivolumab</measure>
      <time_frame>up to 2 years from start of treatment</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</measure>
      <time_frame>up to 2 years from start of treatment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival (PFS)</measure>
      <time_frame>up to 2 years from start of treatment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>up to 2 years from start of treatment</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>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.</measure>
      <time_frame>up to 2 years from start of treatment</time_frame>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Advanced Melanoma</condition>
    <arm_group>
      <arm_group_label>Cohort 1 - Propranolol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Propranolol will be administered as 30 mg orally twice a day, continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 - Propranolol + Naltrexone 4.5 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Propranolol will be administered as 30 mg orally twice a day, continuously.&#xD;
  Naltrexone will be administered as 4.5 mg orally once a day, continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3 - Propranolol + Naltrexone 9 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Propranolol will be administered as 30 mg orally twice a day, continuously.&#xD;
  Naltrexone will be administered as 9 mg orally once a day, continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4 - Propranolol + Naltrexone 25 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Propranolol will be administered as 30 mg orally twice a day, continuously.&#xD;
  Naltrexone will be administered as 25 mg orally once a day, continuously.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propranolol</intervention_name>
      <description>Propranolol will be administered to patients in all cohorts.</description>
      <arm_group_label>Cohort 1 - Propranolol</arm_group_label>
      <arm_group_label>Cohort 2 - Propranolol + Naltrexone 4.5 mg</arm_group_label>
      <arm_group_label>Cohort 3 - Propranolol + Naltrexone 9 mg</arm_group_label>
      <arm_group_label>Cohort 4 - Propranolol + Naltrexone 25 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Naltrexone</intervention_name>
      <description>Naltrexone will be administered to patients in cohorts 2, 3, and 4.</description>
      <arm_group_label>Cohort 2 - Propranolol + Naltrexone 4.5 mg</arm_group_label>
      <arm_group_label>Cohort 3 - Propranolol + Naltrexone 9 mg</arm_group_label>
      <arm_group_label>Cohort 4 - Propranolol + Naltrexone 25 mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age of 18 years or older and able to understand and sign the informed consent form.&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma.&#xD;
  &#xD;
            -  Candidate for standard of care therapy with ipilimumab 3 mg/kg + nivolumab 1 mg/kg.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
  &#xD;
            -  Treatment-naïve or has received any number of prior lines of therapy. Prior targeted&#xD;
               therapy is allowed, but small molecule inhibitors must be discontinued within two&#xD;
               weeks before starting the study.&#xD;
  &#xD;
            -  Life expectancy of at least 6 months.&#xD;
  &#xD;
            -  Presence of at least one accessible site of disease to provide an on-study biopsy for&#xD;
               tumor tissue. The biopsy may be waived after discussion with the Principal&#xD;
               Investigator (PI) if it is deemed unfeasible. The site may be a target lesion as long&#xD;
               as it will not be rendered unmeasurable by the biopsy procedure.&#xD;
  &#xD;
            -  Willingness to undergo tumor biopsy (if archival tumor is not available) prior to&#xD;
               initiation of therapy and while on the study.&#xD;
  &#xD;
            -  Willingness to provide an archival specimen block, if available, for research&#xD;
               purposes.&#xD;
  &#xD;
            -  Normal organ function, defined as:&#xD;
  &#xD;
                 1. Absolute neutrophil count (ANC) &gt;1500/mcL&#xD;
  &#xD;
                 2. Platelets &gt;100,000/mcL&#xD;
  &#xD;
                 3. Hemoglobin (Hb) &gt;9 g/dL&#xD;
  &#xD;
                 4. Albumin &gt;2.5 mg/dL&#xD;
  &#xD;
                 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &lt;2.5 times&#xD;
                    the upper limit of normal (ULN)&#xD;
  &#xD;
                 6. Serum total bilirubin &lt;1.5 times ULN or direct bilirubin &lt; ULN for subjects with&#xD;
                    total bilirubin levels &gt;1.5 times ULN.&#xD;
  &#xD;
            -  Female participants of childbearing potential should have a negative serum pregnancy&#xD;
               test within 72 hours prior to receiving the first dose of study medication.&#xD;
  &#xD;
            -  Female participants of childbearing potential should be willing to use a highly&#xD;
               effective form of contraception (hormonal or intrauterine device) along with a condom&#xD;
               in their male partner, or be surgically sterile, or abstain from heterosexual activity&#xD;
               for a period of at least six months after the last dose of study medication.&#xD;
  &#xD;
            -  Male participants should agree to use an adequate method of contraception starting&#xD;
               with the first dose of study therapy through at least six months after the last dose&#xD;
               of study drug.&#xD;
  &#xD;
            -  Participants must have at least one measurable lesion at baseline by computed&#xD;
               tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation&#xD;
               Criteria in Solid Tumors (RECIST) v1.1 criteria. Tumor sites situated in a previously&#xD;
               irradiated area or in an area subjected to other loco-regional therapy are not&#xD;
               considered measurable unless there has been demonstrated progression in the lesion.&#xD;
  &#xD;
            -  Prior focal radiotherapy is allowed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of untreated brain metastases, unless discussed with the Principal&#xD;
               Investigator (PI) and meet specific criteria for inclusion (treatment-naïve patients&#xD;
               with brain metastases &lt;10 mm, asymptomatic, without significant edema, hemorrhage,&#xD;
               shift, or requirement for steroids or anti-seizure medications, and not in eloquent&#xD;
               areas). These patients may potentially forego initial local treatment of the brain&#xD;
               metastases and have them reassessed after consultation with the Neurosurgery and&#xD;
               Radiation Oncology teams.&#xD;
  &#xD;
            -  Use of corticosteroids to control immune-related adverse events at enrollment.&#xD;
               Participants who previously required corticosteroids for symptom control must be off&#xD;
               steroids for at least two weeks. Low-dose steroid use (=10 mg of prednisone or&#xD;
               equivalent) as corticosteroid replacement therapy for primary or secondary adrenal&#xD;
               insufficiency is allowed.&#xD;
  &#xD;
            -  Failure to recover (i.e., Grade 1 or at baseline) from adverse events due to prior&#xD;
               treatment.&#xD;
  &#xD;
            -  History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity&#xD;
               poorly responsive to steroids with prior anti-PD-1 therapy.&#xD;
  &#xD;
            -  Presence of leptomeningeal disease.&#xD;
  &#xD;
            -  Active autoimmune disease unrelated to the use of immune checkpoint inhibitors that&#xD;
               has required systemic treatment in the past year (e.g., use of disease-modifying&#xD;
               agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g.,&#xD;
               thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or&#xD;
               pituitary insufficiency) is not considered a form of systemic treatment.&#xD;
  &#xD;
            -  Contraindications to the use of propranolol, including:&#xD;
  &#xD;
                 1. Cardiogenic shock.&#xD;
  &#xD;
                 2. Sinus bradycardia greater than first-degree block.&#xD;
  &#xD;
                 3. Severe bronchial asthma.&#xD;
  &#xD;
                 4. Known hypersensitivity to propranolol.&#xD;
  &#xD;
                 5. Requirement for current use of an alternative beta-blocker.&#xD;
  &#xD;
                 6. Uncontrolled diabetes.&#xD;
  &#xD;
                 7. Uncontrolled depression.&#xD;
  &#xD;
                 8. Unstable angina or myocardial infarction within 3 months of Day 1 Cycle 1.&#xD;
  &#xD;
            -  For enrollment into Cohort 2-4 ONLY: Contraindications to the use of naltrexone,&#xD;
               including:&#xD;
  &#xD;
                 1. Participants currently receiving opioid analgesics or anticipated to require&#xD;
                    opioid analgesics in the near future.&#xD;
  &#xD;
                 2. Participants currently dependent on opioids, including those currently maintained&#xD;
                    on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine).&#xD;
  &#xD;
                 3. Participants in acute opioid withdrawal.&#xD;
  &#xD;
                 4. Individuals with a history of sensitivity to naltrexone.&#xD;
  &#xD;
            -  Pregnancy or breastfeeding. If a woman becomes pregnant or suspects she is pregnant&#xD;
               while participating in this study, she should inform her treating physician&#xD;
               immediately. Breastfeeding must be discontinued if the mother is enrolled in this&#xD;
               trial due to the potential risk for adverse events in nursing infants.&#xD;
  &#xD;
            -  Receipt of any other investigational agents or participation in a study of an&#xD;
               investigational agent or use of an investigational device within four weeks of the&#xD;
               first dose of treatment.&#xD;
  &#xD;
            -  Concurrent condition (including medical illness, active infection requiring treatment&#xD;
               with intravenous antibiotics, or presence of laboratory abnormalities) or history of a&#xD;
               prior condition that places the patient at unacceptable risk if treated with the study&#xD;
               drug or confounds the ability to interpret data from the study.&#xD;
  &#xD;
            -  Concurrent, active malignancies in addition to those being studied, except for&#xD;
               cutaneous squamous cell carcinoma or basal cell carcinoma.&#xD;
  &#xD;
            -  Active (non-infectious) pneumonitis.&#xD;
  &#xD;
            -  Hepatitis B (HBV) or Hepatitis C (HCV) acute or chronic infection.&#xD;
  &#xD;
            -  Receipt of a live vaccine&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah Weiss, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Weiss, MD</last_name>
      <phone>732-235-2465</phone>
      <email>saweiss@cinj.rutgers.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rutgers Cancer Institute of New Jersey</name>
        <address>
          <city>New Brunswick</city>
          <state>New Jersey</state>
          <zip>08903</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sarah Weiss, MD</last_name>
        <phone>732-235-2465</phone>
        <email>saweiss@cinj.rutgers.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
      <investigator_full_name>Ryan Stephenson</investigator_full_name>
      <investigator_title>Associate Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>Melanoma</keyword>
    <keyword>Metastatic melanoma</keyword>
    <keyword>Skin cancer</keyword>
    <keyword>Immune checkpoint inhibitors</keyword>
    <keyword>Propranolol</keyword>
    <keyword>Naltrexone</keyword>
    <keyword>Beta-adrenergic blocker</keyword>
    <keyword>Opioid receptor antagonist</keyword>
    <keyword>Tumor microenvironment</keyword>
    <keyword>NK cells</keyword>
    <keyword>T-cells</keyword>
    <keyword>Combination therapy</keyword>
    <keyword>Immunotherapy</keyword>
    <keyword>Ipilimumab</keyword>
    <keyword>Nivolumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propranolol</mesh_term>
      <mesh_term>Naltrexone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968690
  org study id: 092302
  secondary id: Pro2023001214
  nct id: NCT05968690
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Various forms of stress can promote cancer development and growth and negatively impact the
        immune system's response to tumors. Beta-adrenergic and opioid receptors co-exist in many
        cells including immune cells and are integral components of the body's response to stress.
        Pre-clinical studies have demonstrated that dual blockade of these receptors can decrease
        tumor growth and modulate the anti-tumor immune response. This clinical trial investigates
        the safety and potential therapeutic benefits of combining a beta-adrenergic blocker
        (propranolol) and an opioid receptor antagonist (naltrexone) with immune checkpoint
        inhibitors in patients with advanced melanoma.
  This is an open-label, single institution, phase I clinical trial to investigate the safety,
        tolerability, and preliminary efficacy of dose-escalated naltrexone (NTX) in combination with
        propranolol (PRO), ipilimumab (IPI), and nivolumab (NIVO) in patients with advanced melanoma.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: This is an open-label, single institution, phase I study with a 3+3 design of dose escalated naltrexone in combination with propranolol 30 mg bid and ipilimumab 3 mg/kg plus nivolumab 1 mg/kg q3wk for up to 4 doses followed by NIVO monotherapy q4wk in participants with advanced melanoma.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  time frame: initial 28 days of treatment and then for up to 2 years
  measure: Dose-limiting toxicity of naltrexone in combination with propranolol and ipilimumab plus nivolumab
  time frame: initial 28 days of treatment
  measure: Recommended phase 2 dose of naltrexone in combination with propranolol and ipilimumab plus nivolumab
  time frame: up to 2 years from start of treatment
  measure: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  time frame: up to 2 years from start of treatment
  measure: Progression-Free Survival (PFS)
  time frame: up to 2 years from start of treatment
  measure: Overall Survival (OS)
  time frame: up to 2 years from start of treatment
  measure: 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.
  time frame: up to 2 years from start of treatment
  arm group label: Cohort 1 - Propranolol
  arm group type: Experimental
  description: 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.
  arm group label: Cohort 2 - Propranolol + Naltrexone 4.5 mg
  arm group type: Experimental
  description: 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.
  arm group label: Cohort 3 - Propranolol + Naltrexone 9 mg
  arm group type: Experimental
  description: 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.
  arm group label: Cohort 4 - Propranolol + Naltrexone 25 mg
  arm group type: Experimental
  description: 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.
  intervention type: Drug
  intervention name: Propranolol
  description: Propranolol will be administered to patients in all cohorts.
  arm group label: Cohort 1 - Propranolol
  arm group label: Cohort 2 - Propranolol + Naltrexone 4.5 mg
  arm group label: Cohort 3 - Propranolol + Naltrexone 9 mg
  arm group label: Cohort 4 - Propranolol + Naltrexone 25 mg
  intervention type: Drug
  intervention name: Naltrexone
  description: Naltrexone will be administered to patients in cohorts 2, 3, and 4.
  arm group label: Cohort 2 - Propranolol + Naltrexone 4.5 mg
  arm group label: Cohort 3 - Propranolol + Naltrexone 9 mg
  arm group label: Cohort 4 - Propranolol + Naltrexone 25 mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sarah Weiss, MD
  role: Principal Investigator
  affiliation: Rutgers Cancer Institute of New Jersey
  last name: Sarah Weiss, MD
  phone: 732-235-2465
  email: saweiss@cinj.rutgers.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Rutgers, The State University of New Jersey
  investigator full name: Ryan Stephenson
  investigator title: Associate Professor of Medicine
  mesh term: Melanoma
  mesh term: Propranolol
  mesh term: Naltrexone
  sharing ipd: No