Last Update: Mar 26, 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
Phase 1
Recruiting
121
Oct 31, 2019
Mar 07, 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

Leuven,3000,Belgium

Novartis Investigative Site

Recruiting

Liege,4000,Belgium

Novartis Investigative Site

Recruiting

Montreal,Quebec,H3T 1E2,Canada

Novartis Investigative Site

Recruiting

Toronto,Ontario,M5G 2M9,Canada

Novartis Investigative Site

Recruiting

Guangzhou,510060,China

Novartis Investigative Site

Recruiting

Brno,Czech Republic,656 53,Czech Republic

Novartis Investigative Site

Recruiting

Heidelberg,69120,Germany

Novartis Investigative Site

Recruiting

Ulm,89081,Germany

Novartis Investigative Site

Recruiting

Jena,07740,Germany

Novartis Investigative Site

Recruiting

Essen,45147,Germany

Novartis Investigative Site

Recruiting

Shatin New Territories,Hong Kong

Novartis Investigative Site

Recruiting

Budapest,H 1122,Hungary

Novartis Investigative Site

Recruiting

Debrecen,4032,Hungary

Novartis Investigative Site

Recruiting

Aviano,PN,33081,Italy

Novartis Investigative Site

Recruiting

Siena,SI,53100,Italy

Novartis Investigative Site

Recruiting

Napoli,80131,Italy

Novartis Investigative Site

Recruiting

Rozzano,MI,20089,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20132,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20133,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20141,Italy

Novartis Investigative Site

Recruiting

Modena,MO,41124,Italy

Novartis Investigative Site

Recruiting

Seoul,03080,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,05505,Korea, Republic of

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08035,Spain

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08036,Spain

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46010,Spain

Novartis Investigative Site

Recruiting

Hospitalet de LLobregat,Catalunya,08907,Spain

Novartis Investigative Site

Recruiting

Zuerich,8091,Switzerland

Novartis Investigative Site

Recruiting

Taipei,10041,Taiwan

Providence Portland Medical Center

Recruiting

Portland,Ashley Drokin (503-215-6805) email: [email protected] -- Rom Leidner,97123 - Oregon,United States

Columbia University Medical Center- New York Presbyterian

Recruiting

New York,Caitlin Rogers email: [email protected] -- Catherine Shu,10032 - New York,United States

MD Anderson Cancer Center Uni of Te MDACC

Recruiting

Houston,Funda Meric-Bernstam,77030 - Texas,United States

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals