Resumen

El propósito de este estudio es evaluar la preferencia del participante por la hialuronidasa/pembrolizumab coformulada (+) berahialuronidasa alfa administrada por vía subcutánea (SC) versus pembrolizumab (MK-3475) administrado por vía intravenosa (IV) en participantes con múltiples tipos de tumores. No se realizarán pruebas de hipótesis en este estudio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

Pembrolizumab (+) Berahyaluronidase alfa

Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

biological

Pembrolizumab

Administered via IV infusion

Ubicaciones

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, Argentina

Fundación Respirar ( Site 0302)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto San Marcos ( Site 0305)

San Juan, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Estudio de Fase 2 para evaluar la preferencia del paciente por pembrolizumab subcutáneo coformulado con hialuronidasa (MK-3475A) versus la formulación intravenosa de pembrolizumab en participantes con múltiples tipos de tumores (MK-3475A-F11)