Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

PHASE1CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

November 19, 2018

Primary Completion Date

December 4, 2023

Study Completion Date

December 4, 2023

Conditions
Melanoma
Interventions
BIOLOGICAL

Pembrolizumab Dose C

165 mg/mL administered to a final dose of 285 mg via subcutaneous injection

BIOLOGICAL

Pembrolizumab Dose A

130 mg/mL administered to a final dose of 285 mg via subcutaneous injection

BIOLOGICAL

Pembrolizumab Dose B

200 mg administered via intravenous infusion

BIOLOGICAL

Pembrolizumab Dose D

400 mg administered via intravenous infusion

Trial Locations (15)

2193

WITS Clinical Research CMJAH Clinical Trial Site ( Site 0030), Johannesburg

2196

The Medical Oncology Centre of Rosebank ( Site 0026), Johannesburg

Sandton Oncology Medical Group PTY LTD ( Site 0029), Johannesburg

2298

Calvary Mater Newcastle ( Site 0006), Waratah

2444

MNCCI Port Macquarie Base Hospital ( Site 0005), Port Macquarie

2800

Orange Health Services ( Site 0004), Orange

3350

Ballarat Health Services ( Site 0003), Ballarat

4870

Cairns and Hinterland Hospital and Health Service ( Site 0001), Cairns

5000

Royal Adelaide Hospital ( Site 0002), Adelaide

7570

Cape Town Oncology Trials Pty Ltd ( Site 0028), Kraaifontein

20014

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0063), Donostia / San Sebastian

0181

MPOC ( Site 0027), Groenkloof Pretoria

08035

Hospital Universitari Vall d Hebron ( Site 0062), Barcelona

08036

Hospital Clinic i Provincial de Barcelona ( Site 0061), Barcelona

171 64

Karolinska Universitetssjukhuset Solna ( Site 0040), Solna

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03665597 - Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555) | Biotech Hunter | Biotech Hunter