Clinical trial · Interventional
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
NCT04058756CI-TRIAL-00119628active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDR001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PDR001
- description
- All subjects in all combination will be entered in one arm
- interventionNames
- Drug: PDR001
Primary outcomes (2)
- measure
- Frequency and nature of AE and SAE by subject
- timeFrame
- 5 years
- description
- Safety data.
- measure
- Number of subjects with PDR001 dose interruption and/or reduction
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.