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ACTIVE NOT RECRUITING
NCT06099782
PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2023-12-26

Completion Date

2027-02-15

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

BIOLOGICAL

Pembrolizumab

Administered via IV infusion

Locations (45)

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

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

Centro Investigacion Cancer James Lind ( Site 0408)

Temuco, Región de la Araucanía, Chile

ONCOCENTRO APYS-ACEREY ( Site 0400)

Viña del Mar, Región de Valparaíso, 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

Bell Land General Hospital ( Site 1101)

Sakai, Osaka, Japan

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, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Warsaw, Masovian Voivodeship, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)

Koszalin, West Pomeranian Voivodeship, Poland

Zachodniopomorskie Centrum Onkologii ( Site 0703)

Szczecin, West Pomeranian Voivodeship, Poland

Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)

Port Elizabeth, Eastern Cape, South Africa

Medical Oncology Centre of Rosebank ( Site 0805)

Johannesburg, Gauteng, South Africa

Nosworthy Oncology ( Site 0807)

Johannesburg, Gauteng, South Africa

Steve Biko Academic Hospital-Medical Oncology ( Site 0804)

Pretoria, Gauteng, South Africa

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)

Pretoria, Gauteng, South Africa

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)

Sandton, Gauteng, South Africa

Cape Town Oncology Trials ( Site 0802)

Cape Town, Western Cape, South Africa

CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)

Cape Town, Western Cape, South Africa

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)

Adana, Turkey (Türkiye)

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)

Ankara, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 0902)

Izmir, Turkey (Türkiye)