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)
Running, not enrolling · Phase 2
Conditions studied: Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
In brief
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.
Key facts
- Study ID
- NCT06099782
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 147
- Starts
- 2023-12-26
- Expected to finish
- 2027-02-15
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Russell Medical ( Site 0160) — Alexander City, Alabama, United States
- Alaska Oncology and Hematology ( Site 0121) — Anchorage, Alaska, United States
- Highlands Oncology Group-Research Department ( Site 0133) — Springdale, Arkansas, United States
- Marin Cancer Care ( Site 0148) — Greenbrae, California, United States
- Holy Cross Hospital-Clinical Research ( Site 0159) — Fort Lauderdale, Florida, United States
- Mid Florida Hematology and Oncology Center ( Site 0113) — Orange City, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112) — Marietta, Georgia, United States
- Kadlec Clinic Hematology and Oncology ( Site 0103) — Kennewick, Washington, United States
- 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
- Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) — Port Macquarie, New South Wales, Australia
- Frankston Hospital-Oncology and Haematology ( Site 1007) — Frankston, Victoria, Australia
- Centro Investigacion Cancer James Lind ( Site 0408) — Temuco, Araucania, Chile
- Clínica Puerto Montt ( Site 0404) — Port Montt, Los Lagos Region, Chile
- FALP-UIDO ( Site 0401) — Santiago, Region M. de Santiago, Chile
- Oncovida ( Site 0403) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407) — Santiago, Region M. de Santiago, Chile
- Bradfordhill-Clinical Area ( Site 0402) — Santiago, Region M. de Santiago, Chile
- ONCOCENTRO APYS-ACEREY ( Site 0400) — Viña del Mar, Valparaiso, Chile
- CENTRE LEON BERARD-onco dermatology ( Site 0600) — Lyon Cedex08, Auvergne-Rhône-Alpes, France
- Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604) — Caen, Calvados, France
- Clinique Francois Chenieux ( Site 0603) — Limoges, Haute-Vienne, France
- HIA Sainte Anne-Pneumology ( Site 0601) — Toulon, Var, France
- Hôpital Bichat - Claude-Bernard ( Site 0605) — Paris, Île-de-France Region, France
Full record on ClinicalTrials.gov
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