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)

Conditions: Non-Small Cell Lung Cancer; Renal Cell Carcinoma; Melanoma

Summary: the purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa 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.


Eligibility criteria:
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.