Last Update: Jun 17, 2024
An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments
ClinicalTrials.gov Identifier:
Novartis Reference Number:CPDR001X2X01B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Advanced Solid Tumors
Phase1
Recruiting
121
Oct 31, 2019
Apr 30, 2030
All
18 Years - (Adult, Older Adult)

Interventions

Drug

PDR001

PDR001

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.

Study Location

Novartis Investigative Site

Recruiting

Guangzhou,510060,China

Novartis Investigative Site

Recruiting

Brno,Czech Republic,656 53,Czechia

Novartis Investigative Site

Recruiting

Hong Kong,Hong Kong

Novartis Investigative Site

Recruiting

Debrecen,4032,Hungary

Novartis Investigative Site

Recruiting

Budapest,H 1122,Hungary

Novartis Investigative Site

Recruiting

Napoli,80131,Italy

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46010,Spain

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Zuerich,8091,Switzerland

Columbia University Medical Center New York Presbyterian

Recruiting

New York,New York,10032,United States

Providence Portland Medical Center

Recruiting

Portland,Oregon,97123,United States

MD Anderson Cancer Center Uni of Te MDACC

Recruiting

Houston,Texas,77030,United States

Worldwide Contacts

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