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Study on the Safety and Tolerability of Spartalizumab for Patients with Advanced Cancer

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What is this study about?

This clinical trial is focused on studying the safety and tolerability of a medication called spartalizumab. The study involves participants who have previously been part of a Novartis-sponsored trial where they received spartalizumab either alone or in combination with other treatments. The main goal is to gather information on how safe and tolerable spartalizumab is for patients with different types of advanced cancer.

Participants in this study will continue to receive spartalizumab, and researchers will monitor them for any side effects or adverse reactions. The study will also track how long participants are exposed to the medication. This trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study is designed to ensure that participants who are benefiting from spartalizumab can continue their treatment while contributing valuable data to the research.

The trial will run until March 2030, allowing for a comprehensive collection of data over an extended period. This information will help in understanding the long-term effects and safety profile of spartalizumab in treating advanced cancer. Participants are expected to comply with scheduled visits and treatment plans as part of the study requirements.

1 joining the study

Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

Eligibility requires current enrollment in a specific Novartis-sponsored study, receiving spartalizumab alone or with other treatments, and deriving clinical benefit as determined by the investigator.

2 treatment administration

The study involves the administration of spartalizumab, which may be given alone or with other medications. The route of administration is intravenous.

Other medications may include taminadenant, capmatinib, batoprotafib, naporafenib, trametinib dimethyl sulfoxide, ieramilimab, dabrafenib mesylate, canakinumab, lacnotuzumab, and heterodimeric interleukin-15. These are administered either orally, intravenously, or subcutaneously, depending on the specific medication.

3 monitoring and follow-up

Regular visits are scheduled to monitor safety and tolerability. This includes checking for any adverse events or serious adverse events.

The primary focus is on the frequency and nature of these events, as well as any dose interruptions or reductions.

4 study duration

The study is expected to continue until March 7, 2030. Participation involves ongoing treatment and monitoring until this date or until the investigator determines that the treatment is no longer beneficial.

Who Can Join the Study?

  • The patient must sign an informed consent form before joining the study. This means they agree to participate after understanding the study details.
  • The patient must already be part of a specific study sponsored by Novartis and be receiving a treatment called spartalizumab, either alone or with other treatments.
  • The patient must be benefiting from the study treatment, as judged by the doctor in charge of the study.
  • The patient must have followed the rules and requirements of the original study, as checked by the doctor.
  • The patient must be willing and able to attend scheduled visits and follow the treatment plans.

Who Cannot Join the Study?

  • Patients who do not have advanced cancer cannot participate. Advanced cancer means the cancer has spread to other parts of the body and is more serious.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it usually means only certain ages are allowed.
  • Patients who are not part of the specified clinical trial group cannot participate. This means only certain groups of patients are allowed, based on specific characteristics.
  • Patients who are not female or male cannot participate. This means the study is open to both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Universita’ Degli Studi Di Modena E Reggio Emilia Modena Italy
University Of Debrecen Debrecen Hungary
Med Polonia Sp. z o.o. Poznan Poland
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hopital Huriez Lille France
Cctody Lnih Brbwnf Lyon France
Ulnciqfvxdzjkdgbegkvq Eaqob Amn Essen Germany
Iighvxxc Ckzmxi Dzunspkpxcathlfth L'hospitalet De Llobregat Spain
Aetqksgcin Pbynzhnh Hrbctyzb Dg Msudwwuhu Marseille France
Aefzora Ocyankkzzsh Uxxlyyyocpohz Sbvkwf Siena Italy
Hgxiyawt Vfnl dwacyjop Barcelona Spain
Igmbpyyy Pysuzhbebifrtgq Czxpca Cnpfap Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.10.2019
Czechia Czechia
Not recruiting
31.10.2019
France France
Not recruiting
31.10.2019
Germany Germany
Not recruiting
31.10.2019
Hungary Hungary
Not recruiting
31.10.2019
Italy Italy
Not recruiting
31.10.2019
Poland Poland
Not recruiting
31.10.2019
Spain Spain
Not recruiting
31.10.2019

Trial locations

Investigated drugs:

Spartalizumab is a medication being studied for its safety and tolerability. It is used as a single agent, meaning it is given by itself, or in combination with other treatments. The trial aims to gather more information about how safe spartalizumab is for patients and how well patients can tolerate it.

Investigated diseases:

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. It is characterized by the growth of cancer cells that invade nearby tissues and organs. As the disease progresses, it can affect various bodily functions and lead to symptoms such as pain, fatigue, and weight loss. The progression of advanced cancer varies depending on the type of cancer and the organs involved. It often requires complex management to address symptoms and maintain quality of life. Advanced cancer is typically not curable, but treatments may help control its spread and alleviate symptoms.

Trial ID:
2023-508841-42-00
Protocol code:
CPDR001X2X01B
NCT ID:
NCT04058756
Trial Phase:
Human Pharmacology (Phase I) – Other

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