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Clinical Trials in the USA / NCT06099782
Active, not recruiting Phase 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)

NCT06099782 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2023-12-26
Last updated
2026-04-08

Condition(s) studied

Non-Small Cell Lung CancerRenal Cell CarcinomaMelanoma

Investigational drug(s) / intervention(s)

Pembrolizumab (+) Berahyaluronidase alfaPembrolizumab

Pembrolizumab (+) Berahyaluronidase alfa: Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

Pembrolizumab: Administered via IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Russell Medical ( Site 0160) Alexander City Alabama
Alaska Oncology and Hematology ( Site 0121) Anchorage Alaska
Highlands Oncology Group-Research Department ( Site 0133) Springdale Arkansas
Marin Cancer Care ( Site 0148) Greenbrae California
Holy Cross Hospital-Clinical Research ( Site 0159) Fort Lauderdale Florida
Mid Florida Hematology and Oncology Center ( Site 0113) Orange City Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112) Marietta Georgia
Kadlec Clinic Hematology and Oncology ( Site 0103) Kennewick Washington
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) Mar del Plata Buenos Aires
Fundación Respirar ( Site 0302) Buenos Aires Buenos Aires F.D.
Instituto San Marcos ( Site 0305) San Juan Argentina
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) Port Macquarie New South Wales
Frankston Hospital-Oncology and Haematology ( Site 1007) Frankston Victoria
Centro Investigacion Cancer James Lind ( Site 0408) Temuco Araucania
Clínica Puerto Montt ( Site 0404) Port Montt Los Lagos Region
FALP-UIDO ( Site 0401) Santiago Region M. de Santiago
Oncovida ( Site 0403) Santiago Region M. de Santiago
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407) Santiago Region M. de Santiago
Bradfordhill-Clinical Area ( Site 0402) Santiago Region M. de Santiago
ONCOCENTRO APYS-ACEREY ( Site 0400) Viña del Mar Valparaiso
CENTRE LEON BERARD-onco dermatology ( Site 0600) Lyon Cedex08 Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604) Caen Calvados
Clinique Francois Chenieux ( Site 0603) Limoges Haute-Vienne
HIA Sainte Anne-Pneumology ( Site 0601) Toulon Var
Hôpital Bichat - Claude-Bernard ( Site 0605) Paris Île-de-France Region
Bell Land General Hospital ( Site 1101) Sakai Osaka
Tokyo Women's Medical University ( Site 1100) Tokyo Japan
Auckland City Hospital-Cancer & Blood Research ( Site 1051) Auckland New Zealand
Bowen Hospital ( Site 1050) Wellington New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701) Bydgoszcz Kuyavian-Pomeranian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier Warsaw Masovian Voivodeship
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702) Koszalin West Pomeranian Voivodeship
Zachodniopomorskie Centrum Onkologii ( Site 0703) Szczecin West Pomeranian Voivodeship
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808) Port Elizabeth Eastern Cape
Medical Oncology Centre of Rosebank ( Site 0805) Johannesburg Gauteng
Nosworthy Oncology ( Site 0807) Johannesburg Gauteng
Steve Biko Academic Hospital-Medical Oncology ( Site 0804) Pretoria Gauteng
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800) Pretoria Gauteng
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801) Sandton Gauteng
Cape Town Oncology Trials ( Site 0802) Cape Town Western Cape

+ 5 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06099782 on ClinicalTrials.gov ↗ ← All trials in the USA