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New treatment option for Advanced Melanoma
Official title Naltrexone and Propranolol Combined With Immunotherapy
ClinicalTrials.gov ID: NCT05968690
What this study is testing
What is Propranolol?
Propranolol is an investigational medicine, being studied as a potential treatment for advanced melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age of 18 years or older and able to understand and sign the informed consent form.
- Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma.
- Candidate for standard of care therapy with ipilimumab 3 mg/kg + nivolumab 1 mg/kg.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Treatment-naïve or has received any number of prior lines of therapy. Prior targeted therapy is allowed, but small molecule inhibitors must be...
You likely can't join if
- Presence of untreated brain metastases, unless discussed with the Principal Investigator (PI) and meet specific criteria for inclusion...
- Use of corticosteroids to control immune-related adverse events at enrollment. Participants who previously required corticosteroids for symptom...
- Failure to recover (i.e., Grade 1 or at baseline) from adverse events due to prior treatment.
- History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1 therapy.
- Presence of leptomeningeal disease.
- Active autoimmune disease unrelated to the use of immune checkpoint inhibitors that has required systemic treatment in the past year (e.g., use of...
See the full eligibility criteria
Who can join
- Age of 18 years or older and able to understand and sign the informed consent form.
- Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma.
- Candidate for standard of care therapy with ipilimumab 3 mg/kg + nivolumab 1 mg/kg.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Treatment-naïve or has received any number of prior lines of therapy. Prior targeted therapy is allowed, but small molecule inhibitors must be discontinued within two weeks before starting the study.
- Life expectancy of at least 6 months.
- Presence of at least one accessible site of disease to provide an on-study biopsy for tumor tissue. The biopsy may be waived after discussion with the Principal Investigator (PI) if it is deemed unfeasible. The site may...
- Willingness to undergo tumor biopsy (if archival tumor is not available) prior to initiation of therapy and while on the study.
- Willingness to provide an archival specimen block, if available, for research purposes.
- Normal organ function, defined as:
- Absolute neutrophil count (ANC) \>1500/mcL
- Platelets \>100,000/mcL
- Hemoglobin (Hb) \>9 g/dL
- Albumin \>2.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 times the upper limit of normal (ULN)
- Serum total bilirubin \ 1.5 times ULN.
- Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female participants of childbearing potential should be willing to use a highly effective form of contraception (hormonal or intrauterine device) along with a condom in their male partner, or be surgically sterile, or...
- Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through at least six months after the last dose of study drug.
- Participants must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Tumor sites...
- Prior focal radiotherapy is allowed.
What rules you out
- Presence of untreated brain metastases, unless discussed with the Principal Investigator (PI) and meet specific criteria for inclusion (treatment-naïve patients with brain metastases \<10 mm, asymptomatic, without...
- Use of corticosteroids to control immune-related adverse events at enrollment. Participants who previously required corticosteroids for symptom control must be off steroids for at least two weeks. Low-dose steroid use...
- Failure to recover (i.e., Grade 1 or at baseline) from adverse events due to prior treatment.
- History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1 therapy.
- Presence of leptomeningeal disease.
- Active autoimmune disease unrelated to the use of immune checkpoint inhibitors that has required systemic treatment in the past year (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)...
- Contraindications to the use of propranolol, including:
- Cardiogenic shock.
- Sinus bradycardia greater than first-degree block.
- Severe bronchial asthma.
- Known hypersensitivity to propranolol.
- Requirement for current use of an alternative beta-blocker.
- Uncontrolled diabetes.
- Uncontrolled depression.
- Unstable angina or myocardial infarction within 3 months of Day 1 Cycle 1.
- For enrollment into Cohort 2-4 ONLY: Contraindications to the use of naltrexone, including:
- Participants currently receiving opioid analgesics or anticipated to require opioid analgesics in the near future.
- Participants currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine).
- Participants in acute opioid withdrawal.
- Individuals with a history of sensitivity to naltrexone.
- Pregnancy or breastfeeding. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. Breastfeeding must be discontinued if the...
- Receipt of any other investigational agents or participation in a study of an investigational agent or use of an investigational device within four weeks of the first dose of treatment.
- Concurrent condition (including medical illness, active infection requiring treatment with intravenous antibiotics, or presence of laboratory abnormalities) or history of a prior condition that places the patient at...
- Concurrent, active malignancies in addition to those being studied, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
- Active (non-infectious) pneumonitis.
- Hepatitis B (HBV) or Hepatitis C (HCV) acute or chronic infection.
- Receipt of a live vaccine
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.