Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
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: NCT04058756
Novartis Reference Number: CPDR001X2X01B
Last Update: Feb 16, 2023
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.
Interventions
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 Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]