after joining the study, a complete medical history, physical examination, blood tests, and imaging scans are performed to document the current condition of melanoma.

these assessments establish the starting point for measuring any changes during treatment.

based on the study design, you are assigned to one of three groups: the combination of bnt111 plus cemiplimab, bnt111 alone, or cemiplimab alone.

the assignment is done by the study computer system and is not influenced by personal factors.

each treatment cycle begins with an intravenous (iv) administration, which means the medication is delivered directly into a vein.

if assigned to the combination group, you receive bnt111 at a dose of 100 µg as an iv injection and cemiplimab at a dose of 350 mg as an iv infusion on the same day.

if assigned to the bnt111-only group, you receive only the 100 µg iv injection of bnt111.

if assigned to the cemiplimab-only group, you receive only the 350 mg iv infusion of cemiplimab.

the exact frequency (for example, every three weeks) and total number of cycles are defined by the study protocol and continue until disease progression, unacceptable side effects, or the planned end of the study.

at each scheduled visit, the next dose of the assigned medication is given, vital signs are recorded, and blood samples are taken to monitor safety.

any new symptoms or side effects are reported to the study team at these visits.

imaging scans (such as CT or MRI) are performed at least every six weeks, plus or minus one week, after the first dose to evaluate changes in tumor size.

the results are used to determine the objective response rate, which indicates whether the tumor has shrunk, remained stable, or grown.

laboratory tests (including blood counts and chemistry panels) are repeated at each visit to detect any abnormal values.

the study records any treatment‑emergent adverse events, including immune‑related events, and adjusts the dose or stops treatment if needed.

treatment stops when the study protocol defines progression of disease, unacceptable toxicity, or completion of the planned number of cycles.

the decision is based on imaging results, laboratory findings, and clinical evaluation.

after the last dose, follow‑up visits continue at scheduled intervals to assess overall survival and long‑term safety.

these visits may include physical examinations, imaging, and laboratory tests to monitor for late effects.