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NCT04058756 Clinical Trial

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Advanced Solid Tumors Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04058756
Other study ID # CPDR001X2X01B
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 31, 2019
Est. completion date April 30, 2030

Study information
Verified date June 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 121
Est. completion date April 30, 2030
Est. primary completion date April 30, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• PDR001
PDR001

Locations
Country Name City State
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Liege
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Toronto Ontario
China Novartis Investigative Site Guangzhou Guangdong
China Novartis Investigative Site Guangzhou
Czechia Novartis Investigative Site Brno Czech Republic
Czechia Novartis Investigative Site Praha 4
France Novartis Investigative Site Lille
France Novartis Investigative Site Lyon
France Novartis Investigative Site Marseille
France Novartis Investigative Site Marseille
France Novartis Investigative Site Villejuif
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Jena
Germany Novartis Investigative Site Ulm
Hong Kong Novartis Investigative Site High West
Hong Kong Novartis Investigative Site Hong Kong
Hong Kong Novartis Investigative Site Shatin New Territories
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Debrecen
Italy Novartis Investigative Site Aviano PN
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Modena MO
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Rozzano MI
Italy Novartis Investigative Site Siena SI
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Netherlands Novartis Investigative Site Leiden
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Poznan
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Hospitalet de LLobregat Catalunya
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Switzerland Novartis Investigative Site Zuerich
Taiwan Novartis Investigative Site Taipei
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiang Mai
Thailand Novartis Investigative Site Songkhla Hat Yai
United States MD Anderson Cancer Center Uni of Te MDACC Houston Texas
United States Columbia University Medical Center New York Presbyterian New York New York
United States Providence Portland Medical Center Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Switzerland,  Taiwan,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and nature of AE and SAE by subject Safety data. 5 years
Primary Number of subjects with PDR001 dose interruption and/or reduction 5 years
Secondary Number of subjects receiving PDR001 5 years
Secondary Subject's exposure duration 5 years
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