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Clinical Trials in Poland / NCT04058756
Active, not recruiting Phase 1

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 Poland 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
No
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)

FacilityCityRegionStatus
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 Poland

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) Recruiting
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis Recruiting
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies Recruiting
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN) Active, not recruiting
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib Active, not recruiting

Other trials for the same condition

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers Active, not recruiting
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) Recruiting
A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) Recruiting
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors Recruiting
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors 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 Poland