Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05017012
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.

BIOLOGICAL

Pembrolizumab

Participants will receive pembrolizumab 400 mg IV.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Axitinib

Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.

DRUG

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