Study on Long-term Safety of Nivolumab and Drug Combination for Cancer Patients from Previous BMS Trials

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What is this study about?

This clinical trial is focused on studying the long-term safety of the medication nivolumab, either used alone or in combination with other cancer treatments. The study is designed for patients who have previously participated in trials sponsored by BMS, a pharmaceutical company, and are dealing with various types of cancer, collectively referred to as pan tumor. The main goal is to ensure that the treatments continue to be safe for patients over an extended period.

Participants in this study will continue to receive their cancer treatment as they did in their previous trial, which may include nivolumab or other therapies. The study will monitor the occurrence of any side effects, including those that might lead to stopping the treatment, serious side effects, and immune-related side effects. The study will also track the overall survival of participants, which means observing how long patients live after starting the treatment in the study.

The study will run until 2030, allowing researchers to gather comprehensive data on the long-term effects of these cancer treatments. This information will help in understanding the safety and effectiveness of nivolumab and its combinations with other therapies for patients with different types of cancer. Participants will be required to follow the treatment schedule and attend regular check-ups to ensure their safety and the collection of accurate data.

1 joining the study

Upon joining the study, the participant will begin by taking part in a long-term treatment plan. This plan is designed for those who have previously participated in trials involving nivolumab and other cancer therapies.

The main goal is to assess the long-term safety of nivolumab, either alone or combined with other treatments.

2 treatment administration

Participants will receive nivolumab and potentially other cancer therapies. The specific medications and their administration routes include oral and intravenous options.

For example, nivolumab is administered as a solution for infusion, while other medications like capecitabine are taken orally as film-coated tablets.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to evaluate the incidence of adverse events. This includes any side effects related to the treatment, serious adverse events, and immune-mediated reactions.

Participants will also be assessed for overall survival, which is measured from the start of the study until the date of death from any cause or the last known date alive.

4 study duration

The study is expected to continue until August 22, 2030. Participants will remain in the study as long as they meet the eligibility criteria and continue to benefit from the treatment.

The study’s progress will be evaluated periodically to ensure the safety and well-being of all participants.

Who Can Join the Study?

  • Participants must have signed a written informed consent. This means they agree to join the study after understanding what it involves.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, undergo lab tests, and meet other study requirements.
  • Participants must be eligible to continue receiving study treatment as per the rules of the Parent Study. This includes continuing treatment even if the disease seems to progress, as assessed by the study doctor.
  • Participants must be on a treatment break in the Parent Study after showing a long-lasting response or be eligible to restart treatment as defined in the Parent Study.
  • Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study treatment or its evaluation.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or a serious illness.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of certain heart, liver, or kidney problems.

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
Centr Georges Francois Leclerc Dijon France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Jean Perrin Clermont Ferrand France
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Lille Lille France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Onco Clinic Consult S.A. Craiova Romania
Sigmedical Services S.R.L. Suceava Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitaetsklinikum Aachen AöR Aachen Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Instytut Msf Sp. z o.o. Lodz Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Metropolitan Hospital Athens Greece
Ixtzol Igechszr Fltpvielpvsef Omkyqpycddy Rome Italy
Okvpqopddmyphh Lysg Grmi Linz Austria
Hopqcene Uipirfvhwvgff Mfmmphh Ds Vkxodlxwqw Santander Spain
Hfdzdujl Uqksmokgllskp Rjpesqhy Dv Mxiyxt Malaga Spain
Lydzc Gngjwwc Hzhxhuxx Oh Abeyzd Athens Greece
Ijfluzau Rjhkngejn Pzu Lj Sporzl Dij Tztqnd Dybb Aeidmtv Ixfd Skecjs Meldola Italy
Akbkxddrrv Pctrwnzv Hyzvvnqw Dc Mbrsqtmle Marseille France
Atsoegq Oftkfpnejqp Uufwwoguduizn Cqqkfysgvpda Dyxsa Stbmpi E Didlv Slgoria Da Tdcufy Turin Italy
Azppfr Mzpkghn Cpqtsf Srly Thessaloniki Greece
Nmvycmlj Iyfsdzsv Oabvpeklh Icc Meduy Srpcmvetdiqefkbduxhgdtkxthzm Itvwpwyb Bzdmscwl Cracow Poland
Hafmtfty Dm Lu Sobav Csrm I Sflb Pva Barcelona Spain
Arsssoz Oyzygkjypkc Pmtx Gtdpmwsw Xvsta Bergamo Italy
Itusebsh Clkmly Drmzvutdtgbnoibsw L'hospitalet De Llobregat Spain
Fisanxrbk Pbul Lq Ijwuvixnbolkv Bzfewoujf Dke Hyefjpgs Ucexicibqxbrk Lu Pdy Madrid Spain
Kzfpglpo Eiholyiuupjbblmmwsqafzrs Hsazgqrokaoxwvwuk Essen Germany
Iesaqrcr dj Cvvwpawmvhks Hthbxiutdjb Ulrieqaewgyqg du Srkus Ezmruii (qqcgohv Saint Priest En Jarez France
Haqhobze Vwtq dmdavitd Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
05.05.2020
Belgium Belgium
Recruiting
05.05.2020
Czechia Czechia
Recruiting
05.05.2020
France France
Recruiting
05.05.2020
Germany Germany
Recruiting
05.05.2020
Greece Greece
Recruiting
05.05.2020
Italy Italy
Recruiting
05.05.2020
Poland Poland
Recruiting
05.05.2020
Romania Romania
Recruiting
05.05.2020
Spain Spain
Recruiting
05.05.2020

Trial locations

Nivolumab is a medication used in cancer treatment. It works by helping your immune system attack cancer cells. In this trial, it is being studied for its long-term safety when used alone or with other cancer therapies.

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can interfere with essential bodily functions. Cancer can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer can vary greatly depending on the type and location of the cancer, as well as the individual characteristics of the patient. Some cancers grow and spread rapidly, while others grow more slowly. The disease can remain localized or spread to other parts of the body through the blood and lymph systems.

Trial ID:
2023-506914-32-00
Protocol code:
CA209-8TT
NCT ID:
NCT03899155
Trial Phase:
Therapeutic exploratory (Phase II)

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