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Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
NCT04058756 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG PDR001
Study Locations (20)
Other
- Novartis Investigative Site — Leuven
- Novartis Investigative Site — Liège
- Novartis Investigative Site — Guangzhou
- Novartis Investigative Site — Brno
- Novartis Investigative Site — Lille
- Novartis Investigative Site — Lyon
- Novartis Investigative Site — Marseille
- Novartis Investigative Site — Marseille
- Novartis Investigative Site — Villejuif
- Novartis Investigative Site — Essen
- Novartis Investigative Site — Heidelberg
- Novartis Investigative Site — Ulm
- Novartis Investigative Site — High West
New York
- Columbia University Medical Center — New York
Oregon
- Providence Portland Medical Center — Portland
Texas
- MD Anderson Cancer Center Uni of Te — Houston
Ontario
- Novartis Investigative Site — Toronto
Quebec
- Novartis Investigative Site — Montreal
Guangdong
- Novartis Investigative Site — Guangzhou
Thuringia
- Novartis Investigative Site — Jena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04058756
The ClinicalTrials.gov registry entry for NCT04058756 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which PDR001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04058756 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04058756 about?
NCT04058756 is a clinical study titled "Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments". 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.
What is the current status of trial NCT04058756?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2019-10-30. Estimated completion is 2030-04-30.
What conditions does trial NCT04058756 study?
This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04058756?
The interventions under investigation include: PDR001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04058756?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04058756 being conducted?
This trial has 20 study locations across New York, Oregon, Texas, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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