Phase 2 Melanoma Trial, Recruiting

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

Who might be able to join this trial:

For people with skin melanoma (melanoma-specific criteria):

• People who have been diagnosed with stage III skin melanoma (confirmed by laboratory testing of tissue), where the cancer has spread to nearby lymph nodes and can be surgically removed — this includes people with newly diagnosed melanoma that has spread to nearby lymph nodes, people whose melanoma has come back in nearby lymph nodes, people whose melanoma has spread to lymph nodes in more than one region, or people whose lymph node melanoma has no known original skin site

For people with head and neck cancer (SCCHN-specific criteria):

• People who have been diagnosed with a certain type of advanced mouth, throat, voice box, or lower throat cancer (stage III or IVA) that can be surgically removed, and where the tumour has tested negative for HPV

General criteria that apply to everyone in the trial:

• People whose cancer can be measured on scans using standard medical criteria
• People who are being considered for surgery with the goal of curing the cancer
• People aged 18 or older at the time of signing the consent form
• People who are able to provide a stored or newly obtained tumour tissue sample from an area that has not been previously treated with radiation
• People who are generally well enough to care for themselves and carry out light activities (a standard health scoring system rates this as 0 or 1)
• People whose blood test results show that their bone marrow, kidneys, liver, and blood clotting are functioning within acceptable ranges (tested within 4 weeks before the first dose)
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose
• Women who could become pregnant must be willing to use highly effective contraception or avoid heterosexual activity during the trial and for at least 120 days after the last dose
• People living with HIV who are on stable HIV medication, have a sufficiently high immune cell count, and have had an undetectable level of HIV in their blood for at least 12 weeks before starting the trial
• People with a history of hepatitis B who have been on antiviral treatment for at least 4 weeks and have an undetectable hepatitis B viral level before starting the trial
• People with a history of hepatitis C who have completed curative antiviral treatment at least 4 weeks before starting the trial and have an undetectable hepatitis C viral level

Who may not be able to join:

For people with skin melanoma (melanoma-specific criteria):

• People whose melanoma started in the eye (uveal), on a mucous membrane (mucosal), or on the palms, soles, or under the nails (acral)
• People whose melanoma has spread to a small number of distant sites in the body (oligometastatic stage IV)
• People who have had melanoma spread through the skin's lymphatic channels (in-transit metastases) within the past 6 months
• People who have previously had treatment targeting the BRAF or MEK proteins

For people with head and neck cancer (SCCHN-specific criteria):

• People with cancer of the nasopharynx (upper throat behind the nose), nasal cavity, sinuses around the nose, or head and neck cancer from an unknown primary site

General criteria that apply to everyone in the trial:

• People who are currently taking part in another clinical trial involving an experimental treatment, or who have done so within the past 4 weeks
• People who have already received any treatment for the specific cancer being studied in this trial
• People who previously received a type of immune therapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar treatments) for a different cancer, and had to stop that treatment because of a serious immune-related side effect (grade 3 or higher)
• People who have had chemotherapy, targeted drug therapy, or radiation therapy within 2 weeks before the first dose (confirm with trial site regarding recovery requirements)
• People who have received a live or live-attenuated vaccine within 30 days before the first dose (note: inactivated vaccines, mRNA vaccines such as COVID-19 vaccines, and vector-based vaccines are permitted)
• People who have been diagnosed with an immune system disorder, or who have been taking steroid medication or other immune-suppressing drugs within 7 days before the first dose — though people on very low-dose steroids, or topical, eye-drop, or inhaled steroids, may still be eligible (confirm with trial site)
• People who have another cancer that is currently growing or requires active treatment — with some exceptions such as certain skin cancers or cervical cancer in situ that have been successfully treated
• People who have previously received an organ or tissue transplant from another person
• People with an active autoimmune disease that has required systemic medical treatment in the past 2 years — though some conditions such as type 1 diabetes, thyroid conditions managed with hormone replacement, or certain skin conditions not requiring systemic treatment may still be eligible (confirm with trial site)
• People with a history of radiation-related lung inflammation
• People with a history of non-infectious lung inflammation or scarring that required steroid treatment, or who currently have this condition
• People with an active infection that requires treatment with medication given throughout the body (such as oral or intravenous antibiotics)
• People living with HIV who have a history of Kaposi sarcoma or a condition called Multicentric Castleman Disease
• People with currently active hepatitis B or hepatitis C infection
• People with a mental health condition or substance use disorder that would affect their ability to take part in the trial
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients
• People whose overall health, other medical conditions, or test results might affect the trial results or make participation unsafe, as assessed by the treating doctor

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