115
Participants
Start Date
February 10, 2020
Primary Completion Date
July 21, 2025
Study Completion Date
October 1, 2025
Trastuzumab deruxtecan (DS-8201a)
"Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.~Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab."
Trastuzumab deruxtecan (DS-8201a)
"Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.~Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin."
Pembrolizumab
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
Institut PAOLI-CALMETTES, Marsielle
CHUTimone, Marseille
Hospital Teresa Herrera (C.H.U.A.C), A Coruña
Fox Chase Cancer Center, Philadelphia
Center for Cancer & Blood Disorders, Bethesda
Hospital General Univ. Gregorio Marañon, Madrid
MD Anderson Cancer Center, Madrid
Hospital Universitario 12 de Octubre, Madrid
Univ. du Cancer de Toulouse, Toulouse
Cancer Specialists of North Florida (Cbo), Jacksonville
Moffitt Cancer Center, Tampa
Institut Bergonie, Bordeaux
Moffit Cancer Center, Tampa
Hopital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Miguel Servet, Zaragoza
Siteman Cancer Center-Washington University, St Louis
Hope Cancer Center of East Texas, Tyler
CHU de Poitiers, Poitiers
Centre Hospitalier Intercommunal de Créteil, Créteil
Univ. of Cali. San Francisco Medical Center, San Francisco
Institut Gustave Roussy, Villejuif
Yale Cancer Center, New Haven
Massachusetts General Hospital Cancer Center, Boston
Inst. Oncologico Baselga Hospital Quiron, Barcelona
Hospital de la Santa Creu i de Sant Pau, Barcelona
The Royal Marsden NHS Foundation Trust, London
Sarah Cannon Research Institute (SCRI), London
The Christie NHS Fond. Trust, Manchester
Royal Marsden Hosptial, Sutton
Lead Sponsor
Collaborators (1)
AstraZeneca
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY