Last updated 9 days ago
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
144 patients around the world
Available in Chile, Argentina, United States
Merck Sharp & Dohme LLC
10Research sites
144Patients around the world
This study is for people with
Skin cancer
Melanoma
Lung cancer
Non-small cell lung carcinoma
Kidney cancer
Renal cell carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto San Marcos Investigación - San Juan
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Fundación Respirar
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Oncocentro APYS - Valparaíso
Recruiting
Instituto Oncológico FALP - UIDO
Recruiting
James Lind Centro de Investigación del Cáncer - Temuco
Recruiting
Clínica Puerto Montt
Recruiting
Oncovida - Santiago
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
StudyMK-3475A-F11
SponsorMerck Sharp & Dohme LLC
Conditions
MelanomaLung cancerNon-small cell lung carcinomaRenal cell carcinomaKidney cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06099782
