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.

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals