A randomized, double-blind, active-controlled Phase III clinical study of MK-7684A (Vibostolimab with Pembrolizumab) compared to Pembrolizumab in participants with surgically removed high-risk melanoma at stages II–IV.

Résumé de l'étude

This study aims to evaluate the efficacy and safety of an experimental drug MK-7684A (Vibostolimab together with Pembrolizumab) compared to MK-3475 (Pembrolizumab) alone, in patients with high-risk melanoma at stages IIB–IV. Approximately 780 patients per treatment group are expected to participate globally. In Switzerland, about 60 patients will participate in this study. MK-7684A is an investigational treatment. It is an immunotherapy that stimulates the body's immune system to fight cancer. MK-7684A is a combination of two drugs: Vibostolimab (MK-7684) and Pembrolizumab (MK-3475). Vibostolimab (MK-7684) is an antibody that binds to an immune checkpoint inhibitor and can thereby stimulate the T-cells of the immune system to fight cancer more effectively. Pembrolizumab (MK-3475) is also an antibody that inhibits the immune system's suppression by the tumor, thereby enhancing the body's ability to fight the tumor. Pembrolizumab has been approved for the treatment of various cancers, including melanoma, in many countries and is marketed under the name KEYTRUDA®. KEYTRUDA is also approved in some countries for the adjuvant treatment of stage 2 and 3 melanomas. The combination of two drugs in MK-7684A is being investigated as a new cancer immunotherapy, with the potential to improve treatment for patients with high-risk melanoma. The total study duration is approximately 8 years (including 1 year of treatment with the study medication; followed by observation until the tumor worsens, a new cancer treatment begins, or the study ends).

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Intervention étudiée

After detailed information, careful eligibility assessment, and collection of medical history, the participant will be included in the study and randomly assigned (1:1 ratio) to one of the two treatment groups. Depending on the assignment, participants will receive either treatment with MK-7684A or with MK-3475.

• Group A: Receives the drug MK-7684A (Vibostolimab with Pembrolizumab), every three weeks for 17 cycles intravenously.

• Group B: Receives the drug MK-3475, every three weeks for 17 cycles intravenously.

This study is a so-called "double-blind" study. This means that neither the study doctor nor the participants know which group they have been assigned to and therefore do not know whether they are receiving MK-7684A or MK-3475.

Participants visit the study center once every three weeks and receive their assigned therapy (infusion) there. During the study visits, various measures and examinations will also be performed, e.g.: imaging procedures such as CT and/or MRI, electrocardiogram (12-lead ECG), collection of blood, urine, or tissue samples, physical examination including checking vital signs (pulse, blood pressure, etc.).

The treatment includes up to 17 cycles of three weeks (the time between one treatment round and the start of the next), which corresponds to approximately one year, or will be terminated earlier if one of the criteria for stopping therapy is met (e.g., worsening of the disease). Before and after the treatment phase, participants will have additional visits at the study center (before the treatment phase to determine if they are eligible for study participation and after the treatment phase for follow-up). Approximately one month after the end of the treatment phase, all participants will visit the study center. The schedule and content for further follow-up visits depend on the reason why the study medication is no longer administered. Depending on the reason for stopping therapy, imaging, examinations by the treating physician, blood draws, etc. may be included in the visits or only telephone contacts. Those follow-up visits that include examinations will continue until the participant's cancer worsens, the participant starts a new cancer treatment, the participant withdraws from the study, or the study ends. If the participant leaves the study due to worsening of the disease, the participant will continue to be contacted approximately every 12 weeks by phone until the end of the study or withdrawal.

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Maladie en cours d'investigation

Melanoma is a malignant form of skin cancer that occurs when melanocytes (the cells that give skin its color) begin to grow uncontrollably. Melanomas account for less than 2% of skin cancer cases, although 90% of deaths due to skin tumors are associated with melanomas. Worldwide, approximately 324,635 patients were diagnosed with melanoma in 2021, with the standard treatment for localized melanoma being surgical resection and for advanced melanoma, immunotherapy. This study targets participants who have had a cutaneous melanoma (black skin cancer) stage IIB, IIC, III, or IV (stages with high risk of recurrence) completely surgically removed prior to the start of the study. Clinical research data indicate that this patient population has a medical need for better therapies after surgical removal of the tumor to prevent tumor recurrence, despite the therapies already in use. For patients in stages III or IV, whose tumor has been removed, various additional therapeutic measures after surgery (adjuvant therapies) have already established themselves as standard treatment. For patients in stages IIB or IIC, treatment with Pembrolizumab after surgery is a recognized treatment option. For patients in stages I and IIA, the standard procedure after resection is pure observation without treatment.

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Sponsor

MSD Merck Sharpt & Dohme AG, Switzerland, Merck Sharp & Dohme LLC, USA

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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale de Zurich

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Date d'approbation du comité d'éthique

03.02.2023

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Résultats de l'essai