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Clinical Trials in Turkey / 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 Turkey tracker
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 alfaAll Pembrolizumab trials (605) →All ) Berahyaluronidase alfa trials (7) →Pembrolizumab →

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.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Merck Sharp & Dohme LLC trials in Turkey

Other trials for the same condition

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 Turkey