Spots Global Cancer Trial Database for A Study To Evaluate Safety And Therapeutic Activity Of RO6874281 In Combination With Pembrolizumab, In Participants With Advanced Or Metastatic Melanoma
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Trial Identification
Brief Title: A Study To Evaluate Safety And Therapeutic Activity Of RO6874281 In Combination With Pembrolizumab, In Participants With Advanced Or Metastatic Melanoma
Official Title: An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma
Study ID: NCT03875079
Conditions
Study Description
Brief Summary: This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale University, New Haven, Connecticut, United States
University of Iowa, Iowa City, Iowa, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Peter Maccallum Cancer Institute; Clinical Trial Unit, Melbourne, Victoria, Australia
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Hopital Claude Huriez; Sce Dermatologie, Lille, , France
Hôpital de la Timone; Dermatologie, Marseille, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
Institut Gustave Roussy; Dermatologie, Villejuif, , France
Main Military Clinical Hospital named after N.N. Burdenko, Moscow, Moskovskaja Oblast, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin, Moscow, , Russian Federation
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept, Moscow, , Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, , Russian Federation
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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