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

NCT04058756 · tracked via the Priya Life Science USA tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 1

Started

2019-10-30

Last updated

2026-07-28

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

PDR001 →

PDR001: PDR001

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

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.

Primary outcome measure(s)

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

Trial sites (48)

Facility	City	Region
Columbia University Medical Center	New York	New York
Providence Portland Medical Center	Portland	Oregon
MD Anderson Cancer Center Uni of Te	Houston	Texas
Novartis Investigative Site	Leuven	Belgium
Novartis Investigative Site	Liège	Belgium
Novartis Investigative Site	Toronto	Ontario
Novartis Investigative Site	Montreal	Quebec
Novartis Investigative Site	Guangzhou	Guangdong
Novartis Investigative Site	Guangzhou	China
Novartis Investigative Site	Brno	Czechia
Novartis Investigative Site	Lille	France
Novartis Investigative Site	Lyon	France
Novartis Investigative Site	Marseille	France
Novartis Investigative Site	Marseille	France
Novartis Investigative Site	Villejuif	France
Novartis Investigative Site	Jena	Thuringia
Novartis Investigative Site	Essen	Germany
Novartis Investigative Site	Heidelberg	Germany
Novartis Investigative Site	Ulm	Germany
Novartis Investigative Site	Hong Kong	Hong Kong
Novartis Investigative Site	High West	Hong Kong
Novartis Investigative Site	Hong Kong	Hong Kong
Novartis Investigative Site	Debrecen	Hajdu Bihar Megye
Novartis Investigative Site	Budapest	Hungary
Novartis Investigative Site	Milan	MI
Novartis Investigative Site	Milan	MI
Novartis Investigative Site	Milan	MI
Novartis Investigative Site	Rozzano	MI
Novartis Investigative Site	Modena	MO
Novartis Investigative Site	Aviano	PN
Novartis Investigative Site	Siena	SI
Novartis Investigative Site	Naples	Italy
Novartis Investigative Site	Leiden	South Holland
Novartis Investigative Site	Gdansk	Poland
Novartis Investigative Site	Poznan	Poland
Novartis Investigative Site	Seoul	Seoul
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	L'Hospitalet de Llobregat	Barcelona
Novartis Investigative Site	Barcelona	Spain
Novartis Investigative Site	Barcelona	Spain

+ 8 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) Recruiting

Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors Recruiting

Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden Recruiting

A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients Recruiting

Other trials for the same condition

A Study of MGC028 in Participants With Advanced Solid Tumors Recruiting

A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. Recruiting

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors Recruiting

A Clinical Study of YL205 in Patients With Advanced Solid Tumors Recruiting

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04058756 on ClinicalTrials.gov ↗ ← All trials in the USA