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

See if you pre-qualify

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.

Condition 
Advanced Solid Tumors
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
105 participants
Start date 
Oct 31, 2019
Completion date 
Jan 16, 2025
Gender 
All
Age(s)
18 Years and older (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 Locations

Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 2M9
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1E2
Quebec
Canada
France
Novartis Investigative Site
Recruiting
France, 94800
Villejuif
France
Novartis Investigative Site
Recruiting
Marseille, 13273
-
France
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Jena, 07740
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong,
-
Hong Kong
Novartis Investigative Site
Recruiting
Shatin, New Territories,
-
Hong Kong
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Milan, 20132
-
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 952
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-693
-
Poland
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8091
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10041
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Songkhla, 90110
Hat Yai
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10310
-
Thailand
Novartis Investigative Site
Recruiting
Chiang Mai, 50200
-
Thailand

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]