Spots Global Cancer Trial Database for Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
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Trial Identification
Brief Title: Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
Official Title: A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Study ID: NCT03396445
Study Description
Brief Summary: The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.
Detailed Description: Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 0020), Mobile, Alabama, United States
Florida Cancer Specialists ( Site 0002), Sarasota, Florida, United States
The West Clinic, P.C. ( Site 0021), Germantown, Tennessee, United States
FALP-UIDO ( Site 0502), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0501), Santiago, Region M. De Santiago, Chile
Soroka Medical Center-Oncology ( Site 0012), Be'er Sheva, , Israel
Hadassah Ein Kerem Medical Center ( Site 0010), Jerusalem, , Israel
The Chaim Sheba Medical Center - Oncology Institute ( Site 0001), Ramat Gan, , Israel
Seoul National University Hospital-Internal Medicine ( Site 0702), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701), Seoul, , Korea, Republic of
Antoni van Leeuwenhoek Ziekenhuis ( Site 0003), Amsterdam, Noord-Holland, Netherlands
Erasmus MC ( Site 0031), Rotterdam, Zuid-Holland, Netherlands
Hospital Universitario Quiron Madrid ( Site 0043), Pozuelo de Alarcon, Madrid, Spain
Instituto Catalan de Oncologia - ICO ( Site 0044), Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 0041), Madrid, , Spain
Centro Integral Oncologico Clara Campal START Madrid ( Site 0040), Madrid, , Spain
National Taiwan University Hospital-Oncology ( Site 0801), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802), Taipei, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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