Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with berahyaluronidase when administered as a SC injection to participants with advanced solid tumors. Participants will receive SC injections of pembrolizumab (+) berahyaluronidase alfa containing one of 2 different concentrations (Conc) of pembrolizumab, Conc1 and Conc2, corresponding to a pembrolizumab dose level of dose 1 for Arms 1, 2, and 3 and dose 2 for Arm 4.
Official title: A Phase 1 Clinical Study to Evaluate the Bioavailability of Pembrolizumab Via Subcutaneous Injection of MK-3475A, a Formulation of Pembrolizumab With MK-5180, in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2021-09-21
Completion Date
2026-05-19
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Pembrolizumab
Participants will receive pembrolizumab 400 mg IV.
Pemetrexed
Participants may receive 500 mg/m\^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
Carboplatin
Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Paclitaxel
Participants may receive 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Nab-paclitaxel
Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Axitinib
Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.
Cisplatin
Participants may receive 75 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Locations (22)
FALP-UIDO ( Site 0101)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0100)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigación del Cáncer ( Site 0102)
Temuco, Región de la Araucanía, Chile
Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0021)
Budapest, Pest County, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 0020)
Budapest, Hungary
Kansai Medical University Hospital ( Site 0112)
Hirakata, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 0110)
Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 0111)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0114)
Fukuoka, Japan
Osaka International Cancer Institute ( Site 0113)
Osaka, Japan
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 0051)
Port Elizabeth, Eastern Cape, South Africa
Medical Oncology Centre of Rosebank ( Site 0058)
Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital-Medical Oncology ( Site 0057)
Pretoria, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0052)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0053)
Sandton, Gauteng, South Africa
Cape Town Oncology Trials ( Site 0050)
Cape Town, Western Cape, South Africa
Cancercare Rondebosch Oncology-Clinical trials ( Site 0055)
Rondebosch, Western Cape, South Africa
Severance Hospital, Yonsei University Health System ( Site 0062)
Seoul, South Korea
Samsung Medical Center ( Site 0063)
Seoul, South Korea
Hospital Universitario Virgen de la Victoria-Phase I Trials Unit ( Site 0042)
Málaga, Andalusia, Spain
HOSPITAL CLÍNIC DE BARCELONA-Department of Medical Oncology ( Site 0043)
Barcelona, Catalonia, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0040)
Madrid, Madrid, Comunidad de, Spain