Spots Global Cancer Trial Database for Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)
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Trial Identification
Brief Title: Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)
Official Title: A Phase 1 Randomized Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Relative Bioavailability of Subcutaneous Injection Versus Intravenous Infusion in Participants With Advanced Melanoma (KEYNOTE-555)
Study ID: NCT03665597
Conditions
Study Description
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) profile of pembrolizumab (MK-3475) following single subcutaneous (SC) injection of pembrolizumab Dose A versus pembrolizumab Dose C in adults with advanced melanoma. Additionally, the safety and tolerability of pembrolizumab SC injections will be assessed. And, finally, the efficacy of pembrolizumab intravenous (IV) infusion administration will be assessed.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Orange Health Services ( Site 0004), Orange, New South Wales, Australia
Calvary Mater Newcastle ( Site 0006), Waratah, New South Wales, Australia
Cairns and Hinterland Hospital and Health Service ( Site 0001), Cairns, Queensland, Australia
Royal Adelaide Hospital ( Site 0002), Adelaide, South Australia, Australia
Ballarat Health Services ( Site 0003), Ballarat, , Australia
MNCCI Port Macquarie Base Hospital ( Site 0005), Port Macquarie, , Australia
MPOC ( Site 0027), Groenkloof Pretoria, Gauteng, South Africa
WITS Clinical Research CMJAH Clinical Trial Site ( Site 0030), Johannesburg, Gauteng, South Africa
The Medical Oncology Centre of Rosebank ( Site 0026), Johannesburg, Gauteng, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 0028), Kraaifontein, Western Cape, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 0029), Johannesburg, , South Africa
Hospital Universitari Vall d Hebron ( Site 0062), Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona ( Site 0061), Barcelona, , Spain
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0063), San Sebastian, , Spain
Karolinska Universitetssjukhuset Solna ( Site 0040), Solna, , Sweden
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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