Phase 2 Melanoma Trial, Completed

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:

• People who have signed a written consent form before any screening procedures take place
• People aged 18 or older at the time of signing the consent form
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests
• People who have been confirmed through laboratory testing to have skin (cutaneous) melanoma that cannot be surgically removed and has either spread to nearby tissue (Stage III) or to other parts of the body (Stage IV), with disease that can be measured on scans
• People whose melanoma has been confirmed to have gotten worse during or after receiving an approved immunotherapy treatment (called anti-PD-1/PD-L1), meaning they received it for at least 12 weeks in a row, and disease worsening has been confirmed on scans taken 4 to 12 weeks apart (one scan may be enough if new symptoms appeared)
• People whose disease progression on immunotherapy was confirmed no more than 6 months before joining the trial
• People who have previously received at least one, but no more than five, rounds of treatment for advanced melanoma
• People whose body can tolerate further immunotherapy treatment — meaning they did not have to permanently stop immunotherapy due to harmful side effects
• People whose tumour has been tested for a specific genetic change called BRAF mutation, and the result is known
• People with a BRAF V600-positive tumour who have already received a targeted treatment called a BRAF inhibitor (with or without a MEK inhibitor), or in certain circumstances, people who are not suitable for, cannot tolerate, or have declined that targeted treatment after being fully informed of the options (confirm with trial site)
• People who are in reasonably good overall physical health, as assessed using a standard performance scale (confirm with trial site)
• People with adequate bone marrow function, as confirmed by blood tests (confirm with trial site for specific values)
• People with normal lactate dehydrogenase (LDH) blood levels — a marker related to cell activity
• People with adequate liver function, as confirmed by blood tests (confirm with trial site for specific values)
• People with adequate kidney function, based on a kidney filtration rate of at least 30 mL/min
• People with stable and adequate blood clotting, as confirmed by tests (confirm with trial site for specific values)
• People who can provide a tumour tissue sample — either a fresh biopsy taken before treatment starts, or stored (archival) tissue collected no more than 3 years ago
• People at selected trial sites who, after giving additional consent, are willing to provide blood samples before and during treatment, and optionally a tumour biopsy
• Women who could become pregnant must have a negative pregnancy blood test at screening, and must agree to use highly effective contraception during the trial and for 6 months after the last dose of trial treatment
• Women who could become pregnant must agree not to donate eggs during the trial and for 6 months after the last dose of treatment
• Men who are sexually active with a woman who could become pregnant and have not had a vasectomy must agree to use barrier contraception (such as a condom with spermicide, or a partner using a diaphragm with spermicide) during the trial and for 6 months after the last dose, and must not donate sperm during this time

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who have a history of a specific type of melanoma that started in the eye (uveal), hands or feet (acral), or in mucous membranes (mucosal melanoma)
• People who have had a significant autoimmune disease in the last 5 years that required treatment with medicines that suppress the immune system — though some autoimmune thyroid conditions, vitiligo, or psoriasis may be allowed (confirm with trial site)
• People with known primary immune system deficiency disorders affecting immune cells (confirm with trial site for specific conditions)
• People with uncontrolled type 1 diabetes or uncontrolled adrenal gland insufficiency
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection — though people with these infections that are well-controlled on treatment may be eligible (confirm with trial site)
• People who have another cancer that has not been in full remission for at least 2 years — with some exceptions for certain low-risk cancers such as early-stage skin cancers or non-invasive cancers (confirm with trial site)
• People who are currently using, or have used in the last 3 months, medicines that suppress the immune system, including regular steroid medications above a low threshold dose (confirm with trial site for specific details)
• People who have received other cancer treatments — including chemotherapy, radiation, or other experimental treatments — within 3 weeks before the first trial dose (or 6 weeks for a specific drug type called nitrosureas)
• People who still have side effects from previous cancer treatments rated above a mild level (above Grade 1), with some exceptions such as hair loss or mild nerve-related symptoms (confirm with trial site)
• People who have had a local or body-wide infection requiring antibiotic treatment within 2 weeks before the first dose of trial treatment
• People who have had their spleen removed
• People who have had major surgery requiring general anaesthesia within 4 weeks before screening, have not fully recovered, or have planned surgery during the trial
• People who have new or growing cancer spread to the brain or spine found during screening — though people with previously treated and stable brain or spine metastases may be eligible under specific conditions (confirm with trial site)
• People with cancer that has spread to the membranes surrounding the brain or spinal cord (leptomeningeal disease)
• People with a history of or current significant heart or cardiovascular problems, including uncontrolled irregular heartbeat, a heart attack or blood clot within the last 6 months, certain types of heart inflammation, or moderate-to-severe heart failure (confirm with trial site for specific conditions)
• People who have received a live vaccine within 28 days before the planned start of trial treatment
• People with a known allergy or sensitivity to the trial drugs or their ingredients
• People with a serious ongoing illness or personal circumstances — including psychological, family, or location-related factors — that would make it difficult to follow the trial requirements
• People who have previously been treated with either of the specific trial drugs: BNT111 or cemiplimab

Additional criteria for a second phase of treatment (add-on therapy) within the trial:

People already participating in certain parts of the trial may be considered for an additional treatment phase if their disease has progressed. This requires confirmed progression on scans, signing a new consent form, meeting updated health and contraception requirements, having no new or growing brain or spine metastases, and not currently using immune-suppressing medicines above allowed levels. Side effects from earlier trial treatment must also have reduced to a mild level, and the add-on treatment must begin within 6 weeks of confirmed progression (confirm with trial site for full details).

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