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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04058756

Enrollment

120

Registered

2019-08-16

Start date

2019-10-30

Completion date

2030-04-30

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Phase Ib, PDR001, PD-1, continued access

Brief 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.

Interventions

DRUGPDR001

PDR001

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Frequency and nature of AE and SAE by subject	5 years	Safety data.
Number of subjects with PDR001 dose interruption and/or reduction	5 years	—

Secondary

Measure	Time frame
Number of subjects receiving PDR001	5 years
Subject's exposure duration	5 years

Countries

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

Contacts

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026