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ACTIVE NOT RECRUITING
NCT05201066
PHASE2

Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Official title: An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Key Details

Gender

All

Age Range

12 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-02-13

Completion Date

2028-02-14

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

decitabine

Solution for intravenous infusion

DRUG

spartalizumab

Solution for intravenous infusion

DRUG

sabatolimab

Solution for intravenous infusion

DRUG

azacitidine

Solution for subcutaneous injection or intravenous infusion

DRUG

venetoclax

Tablet for oral administration

DRUG

INQOVI (oral decitabine)

Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Locations (24)

Oregon Health Sciences University

Portland, Oregon, United States

Huntsman Cancer Institute Univ of Utah

Salt Lake City, Utah, United States

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Florianópolis, Santa Catarina, Brazil

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Alexandroupoli, Greece

Novartis Investigative Site

Pátrai, Greece

Novartis Investigative Site

Brescia, BS, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Fukushima, Japan

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Badalona, Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Zurich, Switzerland

Novartis Investigative Site

Izmir, Turkey (Türkiye)