Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Advanced Solid Tumors

Eligibility:

All Genders

18-100 years

Phase:

PHASE1

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 combinat...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 30 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2030

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04058756

Start Date

October 30 2019

End Date

April 30 2030

Last Update

October 7 2025

Active Locations (48)

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Page 1 of 12 (48 locations)

1

Columbia University Medical Center

New York, New York, United States, 10032

2

Providence Portland Medical Center

Portland, Oregon, United States, 97123

3

MD Anderson Cancer Center Uni of Te

Houston, Texas, United States, 77030

4

Novartis Investigative Site

Leuven, Belgium, 3000