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Study of BNT111 and cemiplimab in patients with advanced melanoma who have not responded to other therapies

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves patients with advanced melanoma, a type of skin cancer that has reached stage III or IV. Melanoma at these stages is difficult to remove surgically and often does not respond to standard treatment. Two drugs are being tested in the study: BNT111 and cemiplimab. BNT111 is a new drug that contains substances such as gindameran, vibosameran, enomimeran, and ontasameran, while cemiplimab is a drug already used to treat certain cancers.

The aim of the study is to see how well these drugs work together or separately in fighting melanoma that does not respond to other therapies. Study participants will be randomly assigned to one of two groups, where they will receive either both drugs or only one of them. The study aims to assess whether the combination of these drugs can increase the effectiveness of treatment compared to using them separately.

The study involves regular visits during which patients will receive the drugs as intravenous infusions. The study will last up to 104 weeks and is scheduled to end in late 2025. During the study, the body's response to treatment and any side effects will be monitored. The goal is to assess whether the drugs can reduce the size of the tumor or slow its growth.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline evaluation

    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.

  2. Step 2

    Randomization

    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.

  3. Step 3

    Start of treatment cycle

    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.

  4. Step 4

    Regular clinic visits

    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.

  5. Step 5

    Tumor response assessment

    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.

  6. Step 6

    Continuous safety monitoring

    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.

  7. Step 7

    Criteria for ending treatment

    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.

  8. Step 8

    Post‑treatment follow‑up

    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.

Who can join the trial?

19 criteria

  • The patient must sign a written informed consent form before initiating any study procedure.
  • Patients with BRAF V600-positive tumors should have previously received treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor).
  • The patient must have adequate bone marrow function, which means: a) Neutrophil count (a type of white blood cell) should be at least 1.5 x 10^9/L without the use of granulocyte-stimulating factor. b) Hemoglobin should be at least 9.0 g/dL. c) The platelet count should be at least 100 x 10^9/L.
  • The patient must have a normal serum LDH level.
  • The patient must have adequate liver function, which means: a) AST and ALT levels (liver enzymes) should not exceed three times the normal range. b) Bilirubin levels (bile pigment) should not exceed 1.5 times the normal range, except in patients with Gilbert's syndrome.
  • The patient should have adequate renal function, as assessed by a glomerular filtration rate (eGFR) of at least 30 mL/min.
  • The patient should have stable blood clotting, which means: a) The INR or prothrombin time should not exceed 1.5 times the normal range, unless the patient is taking anticoagulants. b) Activated partial thromboplastin time (aPTT) should not exceed 1.5 times the normal range unless the patient is taking anticoagulants.
  • Patients must provide tumor biopsy samples before the study begins.
  • Women of reproductive potential must have a negative pregnancy test before the study and agree to use effective contraception during the study and for 6 months after the study.
  • Women of reproductive potential must agree not to donate eggs for assisted reproduction during the study and for 6 months after the study.
  • Sexually active men with women of reproductive potential must use barrier methods of contraception and not donate semen during the study and for 6 months after the study.
  • Patients must have an ECOG (Eco-Grade of Health Outcomes) score of 0 or 1.
  • The patient must be at least 18 years of age on the date the consent form is signed.
  • The patient must be willing and able to comply with the schedule of visits, treatments, laboratory tests, and other study requirements.
  • The patient must have histologically confirmed, unresectable stage III or IV melanoma and measurable disease.
  • The patient must have confirmed disease progression following anti-PD-1/PD-L1 therapy for melanoma.
  • The patient must have received at least one, but no more than five, lines of prior therapy for advanced disease.
  • The patient must be able to tolerate additional anti-PD-1/PD-L1 therapy.
  • The patient must have known BRAF mutation status.

Who cannot join the trial?

8 criteria

  • Patients must not participate in the study if they have other serious medical conditions that may affect the study results.
  • Patients must not participate if they are pregnant or breastfeeding.
  • Patients must not participate if they are taking other anticancer medications that may interfere with the study drugs.
  • Patients must not participate if they are allergic to any of the ingredients in the study drugs.
  • Patients must not participate if they have had an organ transplant.
  • Patients must not participate if they have active infections that may affect their health during the study.
  • Patients must not participate if they have heart problems that may pose a risk during the study.
  • Patients must not participate if they have liver or kidney problems that may affect how the drugs are processed in the body.
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Investigated drugs

  • BNT111

    is an experimental drug being used in clinical trials to stimulate the immune system to fight cancer cells. It is being studied as a treatment for patients with advanced melanoma who do not respond to standard therapies.

  • Cemiplimab

    is an immunotherapy drug that works by blocking the PD-1 protein on the surface of immune cells. This allows these cells to attack cancer cells more effectively. Cemiplimab is used to treat patients with advanced melanoma who do not respond to other forms of therapy.

What is already known about the treatment

  • BNT111

    BNT111 is an injectable drug currently being studied in clinical trials as a potential treatment for patients with advanced melanoma (stage III and IV) who do not respond to standard anti-PD-1/PD-L1 therapies. BNT111 works by stimulating the immune system to recognize and destroy cancer cells. It is a modern immune therapy designed to enhance the body's response to cancer.

  • Cemiplimab

    Cemiplimab is an intravenously administered drug already used to treat certain types of skin cancer and is currently being studied in combination with BNT111 for the treatment of advanced melanoma. It works by blocking the PD-1 protein on the surface of immune cells, allowing them to attack cancer cells more effectively. Cemiplimab is classified as a monoclonal antibody and is part of an immune therapy that enhances the body's natural ability to fight cancer.

Investigated diseases

Melanoma (stages III and IV) – This is a type of malignant tumor that develops from pigment cells in the skin called melanocytes. In stage III, melanoma spreads to nearby lymph nodes, which means that cancer cells are present outside the original tumor site. Stage IV is characterized by metastasis to distant organs such as the lungs, liver, or brain. Melanoma can grow quickly and aggressively, and its progression depends on many factors, including the location and size of the tumor and the presence of metastases. Early detection and monitoring are key to understanding its course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509513-36-00Protocol codeBNT111-01Estimated enrolment184 patientsSponsorBioNTech SE

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