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

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: PDR001

• Registration Number: NCT04058756
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Study Start: 2019-10-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDR001	PDR001	All subjects in all combination will be entered in one arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of subjects receiving PDR001	5 years
Subject's exposure duration	5 years

Trial Locations

Locations (4)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

MD Anderson Cancer Center Uni of Te; 🇺🇸 Houston, Texas, United States

Novartis Investigative Site; 🇹🇭 Chiang Mai, Thailand