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Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

NCT04058756

Active Not RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Advanced Solid Tumors

Interventions: PDR001

Countries: United States, Belgium, Canada, China, Czechia, France, Germany, Hong Kong

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment,
* Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study
* Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.
Locations (48)
  • New York, New York, United States
  • Portland, Oregon, United States
  • Houston, Texas, United States
  • Leuven, Belgium
  • Liège, Belgium
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Guangzhou, Guangdong, China
  • Guangzhou, China
  • Brno, Czechia
  • Lille, France
  • Lyon, France
  • Marseille, France
  • Marseille, France
  • Villejuif, France
  • Jena, Thuringia, Germany
  • Essen, Germany
  • Heidelberg, Germany
  • Ulm, Germany
  • Hong Kong, Hong Kong, Hong Kong
  • High West, Hong Kong
  • Hong Kong, Hong Kong
  • Debrecen, Hajdu Bihar Megye, Hungary
  • Budapest, Hungary
  • Milan, MI, Italy
  • Milan, MI, Italy
  • Milan, MI, Italy
  • Rozzano, MI, Italy
  • Modena, MO, Italy
  • Aviano, PN, Italy
  • + 18 more on CT.gov