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)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

September 21, 2021

Primary Completion Date

September 26, 2026

Study Completion Date

September 26, 2026

Conditions
Advanced or Metastatic Solid Tumors
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.

Trial Locations (22)

1062

Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 0020), Budapest

1122

Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0021), Budapest

2196

Medical Oncology Centre of Rosebank ( Site 0058), Johannesburg

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0053), Sandton

6055

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 0051), Port Elizabeth

7570

Cape Town Oncology Trials ( Site 0050), Cape Town

7700

Cancercare Rondebosch Oncology-Clinical trials ( Site 0055), Rondebosch

28009

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0040), Madrid

29010

Hospital Universitario Virgen de la Victoria-Phase I Trials Unit ( Site 0042), Málaga

4800827

James Lind Centro de Investigación del Cáncer ( Site 0102), Temuco

7500921

FALP-UIDO ( Site 0101), Santiago

8420383

Bradfordhill ( Site 0100), Santiago

573-1191

Kansai Medical University Hospital ( Site 0112), Hirakata

362-0806

Saitama Prefectural Cancer Center ( Site 0110), Ina-machi

411-8777

Shizuoka Cancer Center ( Site 0111), Nagaizumi-cho,Sunto-gun

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 0114), Fukuoka

541-8567

Osaka International Cancer Institute ( Site 0113), Osaka

0001

Steve Biko Academic Hospital-Medical Oncology ( Site 0057), Pretoria

0181

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0052), Pretoria

03722

Severance Hospital, Yonsei University Health System ( Site 0062), Seoul

06351

Samsung Medical Center ( Site 0063), Seoul

08036

HOSPITAL CLÍNIC DE BARCELONA-Department of Medical Oncology ( Site 0043), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY