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NCT05201066Active, not recruitingPhase 2

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.

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.

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
33 (actual)
First submitted
3 Jan 2022
Start date
28 Feb 2023
Primary completion date
14 Feb 2028
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05201066
EU CT number
2024-515281-14-00
EudraCT number
2021-004422-30

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 33
  • From 28 Feb 2023 to the primary completion date, 14 Feb 2028
  • 23 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.

Lab values

  • Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.

Other

  • Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
  • Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume).
  • Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
  • Local access to commercially available sabatolimab for parent protocol indications.
    • Other protocol-defined Inclusion/Exclusion may apply.

Who the study is looking for

  • Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study.
  • Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
  • Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
  • Written informed consent obtained prior to enrolling in the roll-over study.

Age in the registry: 12 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
FlorianópolisBrazilUnknown status
Novartis Investigative Site
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VancouverCanadaUnknown status
Novartis Investigative Site
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ZurichSwitzerlandUnknown status
Novartis Investigative Site
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ChangchunChinaUnknown status
Novartis Investigative Site
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TianjinChinaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceActive, not recruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Novartis Investigative Site
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FukushimaJapanUnknown status
Novartis Investigative Site
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Kuala LumpurMalaysiaUnknown status
Oregon Health Sciences University
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PortlandUnited StatesUnknown status
Huntsman Cancer Institute Univ of Utah
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Salt Lake CityUnited StatesUnknown status
Novartis Investigative Site
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IzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.