Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 2 NCT06099782

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Non-Small Cell Lung Cancer Renal Cell Carcinoma Melanoma

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa \[MK-3475A\] administered subcutaneously (SC) over pembrolizumab \[MK-3475\] administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.
Кой може да участва
Inclusion Criteria: * Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type: * Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition. * Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status. * Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy. * Has a life expectancy of at least 3 months. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention. Exclusion Criteria: * Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Melanoma participants with ocular, mucosal, or conjunctival melanoma. * Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization. * Has received prior radiotherapy for RCC. * RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava. * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. * Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. * Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has active infection requiring systemic therapy. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has history of allogeneic tissue/solid organ transplant corticosteroids. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has not adequately recovered from major surgery or have ongoing surgical complications.
Места на провеждане 10
Argentina (1)
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata , Buenos Aires
Австралия (1)
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Port Macquarie , New South Wales
Chile (1)
Centro Investigacion Cancer James Lind ( Site 0408)
Temuco , Araucania
Франция (1)
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Lyon Cedex08 , Auvergne-Rhône-Alpes
Япония (1)
Bell Land General Hospital ( Site 1101)
Sakai , Osaka
New Zealand (1)
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Auckland
Полша (1)
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
South Africa (1)
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
Port Elizabeth , Eastern Cape
Турция (1)
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
Adana
САЩ (1)
Russell Medical ( Site 0160)
Alexander City , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.12.2023
Крайна дата
15.02.2027
Регистрационен номер
NCT06099782
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.