Clinical study of MK-2870 in individuals with pre-treated endometrial carcinoma

Zusammenfassung der Studie

This study is being conducted to test the safety of MK-2870. It is also being investigated how well MK-2870 works compared to two standard chemotherapies and whether participants receiving MK-2870 live longer and/or progression-free compared to those receiving standard chemotherapy, and have a better quality of life. Approximately 710 patients are expected to participate worldwide. In Switzerland, approximately 20 patients are expected to participate in this study. MK-2870 is an experimental drug and belongs to the class of antibody-drug conjugates. It consists of an antibody linked to a chemotherapy drug. Antibodies bind to specific targets on cells and normally help the immune system fight foreign substances like bacteria or viruses. The antibody in MK2870 binds to the target TROP2 (trophoblast antigen 2), which is found on many cancer cells and only a few normal cells. This allows the chemotherapy drug in MK2870 to come into specific contact with cancer cells. MK-2870 has shown promising activity as a monotherapy against tumors that were resistant to standard therapies in the ongoing phase 1/2 study (MK-2870-001). This phase 3 study is now investigating whether these observations can be confirmed or not. Doxorubicin belongs to a group of substances that can inhibit cell growth or kill them and is widely used in cancer treatment. It inhibits the production of nucleic acids, the components of a cell's genetic material. Paclitaxel also inhibits cell growth, but through a disruption of cell division. The total duration of the study is approximately 4 years.

(BASEC)

Untersuchte Intervention

After thorough counseling, a detailed 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-2870 or one of 2 standard chemotherapies.

• Group A: receives the experimental drug MK-2870.

• Group B: receives either doxorubicin or paclitaxel.

For participants in Group B, the study physician will choose which of the 2 standard chemotherapies will be administered. Participants must remain on the selected chemotherapy for the entire treatment duration.

MK-2870, doxorubicin, and paclitaxel are all administered through a needle in the arm. This is referred to as intravenous (i.v.) infusion. MK2870 is administered once every 2 weeks, doxorubicin once every 3 weeks, paclitaxel once a week for 3 out of 4 weeks.

This study is an open-label study. This means that both the participant and the study physician, as well as the sponsor, know which group the patient has been assigned to.

Participants visit the study center once every 2 weeks (MK-2870), once every 3 weeks (doxorubicin), or once a week for 3 out of 4 weeks (paclitaxel) to receive their assigned therapy. As part of the study visits, various measures and examinations will also be conducted, such as imaging procedures like CT, MRI, PET, as well as blood, urine, or tissue sample collections, and physical examinations including vital signs monitoring (pulse, blood pressure, etc.). This list is not exhaustive, and other examinations may also be performed.

During and after the treatment phase, health status will be regularly monitored for any potential progression of the cancer disease with imaging examinations (for example, CT and/or MRI scans). If your cancer worsens, you may have the option to continue receiving the investigational drug. Your study physician will discuss this with you. You may be asked to sign an additional consent form. In case of disease worsening, participants will visit the study center at least one more time for safety follow-up visits.

After the last visit to the study center as part of the study, the study physician or study team will contact you approximately every 12 weeks or at shorter intervals to check your health status.

(BASEC)

Untersuchte Krankheit(en)

Endometrial carcinoma, which is the most common cancer of the uterus (92% of cases), occurs in the uterine lining. It is the second most common gynecological cancer worldwide. The incidence and mortality of endometrial carcinomas in society are increasing. The currently unapproved standard therapy for patients with advanced endometrial carcinoma consists initially of platinum-based chemotherapy and immunotherapy, either as a combined therapy or sequential therapies. For patients who have already been treated with these drugs, further treatment options are limited, and there remains an unmet medical need for the treatment of this disease. This study evaluates a new therapeutic approach in which chemotherapy specifically binds to cancer cells, which is intended to reduce side effects on healthy cells. Participants must be in good general health and meet certain laboratory values to be eligible for the study. The laboratory values must reflect adequate organ function (for example, of the blood system, kidneys, and liver).

(BASEC)

Sponsor

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

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

18.04.2024

(BASEC)

Ergebnisse der Studie