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

Novartis

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: PDR001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04058756

CPDR001X2X01B

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

PDR001

Experimental group

Description:

All subjects in all combination will be entered in one arm

Treatment:

Drug: PDR001