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

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04058756

Run by

Novartis Pharmaceuticals

People needed

120

Starts

2019-10-30

Expected to finish

2030-04-30

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• MD Anderson Cancer Center Uni of Te — Houston, Texas, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Guangzhou, China
• Novartis Investigative Site — Brno, Czechia
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Jena, Thuringia, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong, Hong Kong
• Novartis Investigative Site — High West, Hong Kong
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Debrecen, Hajdu Bihar Megye, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Milan, MI, Italy

Full record on ClinicalTrials.gov

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