Phase 1 Melanoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand the study and are willing to sign a written consent form before any study procedures begin
• People aged 18 years or older
• People who have a confirmed solid tumour or lymphoma that is advanced, cannot be surgically removed, or has come back and is getting worse since their last cancer treatment, and for which no standard treatment options remain
• People who have at least one tumour that can be injected directly and measured on scans
• People with a past hepatitis B or C infection may be eligible if their liver is still functioning well enough
• People living with HIV may be eligible if they have been on established HIV medication (HAART) for at least 4 weeks before joining, have a very low level of HIV in their blood (under 400 copies/mL), and have a healthy enough immune cell count (CD4+ cells at or above 350 cells/uL)
• People with adequate bone marrow function (confirm with trial site for specific values)
• People with adequate liver function (confirm with trial site for specific values)

Who may not be able to join:

• People who have had another active cancer in the past 2 years, except for certain skin cancers or early-stage cancers of the cervix or breast that have already been successfully treated
• People who have had major surgery within 4 weeks before the first dose of the study drug
• People who have brain metastases (cancer that has spread to the brain) that have not been treated, are located in the lower back part of the brain (posterior fossa), or involve the lining of the brain — though some people with previously treated, stable brain metastases may be considered on a case-by-case basis
• People who have an abnormal heart rhythm measurement (QTc interval greater than 470 milliseconds) when their electrolyte levels are normal
• People who are pregnant or breastfeeding at the time of screening
• Women who are able to become pregnant and are not willing to use a highly effective form of contraception
• People with high blood pressure that is not well controlled (confirm with trial site for specific values)
• People who have received another experimental treatment within either 5 half-lives of that treatment or 4 weeks before the first study dose, whichever is the shorter period
• People who have had a major heart-related event within the 6 months before starting the study drug
• People who have a known allergic reaction to any ingredient in the study drug ONM-501
• People who have an active infection that requires treatment with medication taken throughout the body (such as antibiotics or antivirals)
• People who are already taking part in another clinical trial that involves a treatment

Additional criteria for people in the combination treatment part of the trial (ONM-501 with cemiplimab):

• People who have a known allergic reaction to any ingredient in cemiplimab
• People who have an active autoimmune disease or a recent history of a condition that required more than 10 mg per day of steroid medication (such as prednisone)
• People who currently need ongoing steroid medication to manage a medical condition

Important: Always verify eligibility with the trial site directly before applying.