A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berah… (NCT06099782) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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)
United States147 participantsStarted 2023-12-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1