83
Participants
Start Date
June 24, 2019
Primary Completion Date
July 14, 2022
Study Completion Date
July 14, 2022
RO6874281
"Part I Safety Run in:~Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.~Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study.~Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome).~Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule."
Pembrolizumab
"Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks).~Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome)~Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes)"
Melanoma Institute Australia, North Sydney
UZ Antwerpen, Edegem
Peter Maccallum Cancer Institute; Clinical Trial Unit, Melbourne
UZ Leuven Gasthuisberg, Leuven
Hôpital de la Timone; Dermatologie, Marseille
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona
Centre Eugene Marquis; Service d'oncologie, Rennes
University of Iowa, Iowa City
Hopital Claude Huriez; Sce Dermatologie, Lille
Institut Gustave Roussy; Dermatologie, Villejuif
Main Military Clinical Hospital named after N.N. Burdenko, Moscow
Russian Oncology Research Center n.a. N.N. Blokhin, Moscow
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept, Moscow
Yale University, New Haven
Beth Israel Deaconess Med Ctr, Boston
Dana Farber Cancer Institute, Boston
Princess Margaret Cancer Centre, Toronto
Jewish General Hospital, Montreal
"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg
Hospital Universitari Vall d'Hebron; Oncology, Barcelona
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona
Hoffmann-La Roche
INDUSTRY