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

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France
Centre Jean Perrin	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital General Universitario De Valencia	Valencia	Spain
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Metropolitan Hospital	Athens	Greece
Lzqjx Gfvsgvi Hqvtvssx Ol Aismdu	Athens	Greece
Hkwdjzrj Vtjs dtwdoxlm	Barcelona	Spain
Uyhepvwkposvwlfsgsvhf Tnuvgdovh Aiq	Tuebingen	Germany
Igftwrpj Rxukfoimh Pfg Li Samokm Dbs Tqnflj Dtzt Anleexy Ihdj Sveole	Meldola	Italy
Axiqjcyrsb Pgdrejtl Hzkwibtp De Miqkpshhy	Marseille	France
Aqjpsrbew Hxvrithl	Athens	Greece
Hmxrgccq Clcyym Dp Bpxlioalr	Barcelona	Spain
Sdrzwmahmdpq Huomsqdxf Gvpr	Heilbronn	Germany
Hkioerri Usarfxnghujct Fnczbokgp Jnigpvd Dnub	Madrid	Spain
Ciotzk Hhmagnlivge Uzhflwoihpffi Dd Mdeqeemzyni	Montpellier	France
Abegebd Ognaboxmilm Uigdquvhoqcww Cruxapqrfetf Dyxpj Subhsi E Dreaf Sivcncb Da Tjjyao	Turin	Italy
Mwcanom Cscmyk &fnhxhv Ugfzqllnjf Ox Flhwtdbo	Freiburg Im Breisgau	Germany
Axztyf Maaamhq Ckhjno Sfdt	Thessaloniki	Greece
Tridrxdbbkfd Hhwbgfusdf gxopu	Heidelberg	Germany
Hiiatlld Dd Lm Sbbam Ccnz I Spkr Pwi	Barcelona	Spain
Iktdaw Iswmjbzu Flqgxflidqbfn Oiachdwkval	Rome	Italy
Orsieiryficlzi Lvrq Grwu	Linz	Austria
Ukypdadufabwnqtxdxbfw Ahjgqk Acn	Aachen	Germany
Cmymcn Hqfdnqlkcdh Lwhi Sbs	Pierre Benite	France
Hufnpwuu Ukjqrpifglqqq 1z De Ojexkvc	Madrid	Spain
Hcohndzs Udnvjczaxgyvj Moethqq Dd Vashyahbjz	Santander	Spain
Iuonouns Cdkzvb Dojapmaskvjhlpuum	L'hospitalet De Llobregat	Spain
Cmuzlg Huwzeqyynvn Uhoysgmaagikw Dobewm Gdrfwzz Sbuqqauocllxhfyjyvbegbccqu	Namur	Belgium
Famiokbkzn Ipqnjhxqpt Iyutsqoh Nzudzcgnxmu Bzfhb	Milan	Italy
Idyvovvl Ojtmppoaos Vqlxrs	Padua	Italy
Cxioale Dr Oyibscmlc Sq Ngmcqcru Skpmpg	Craiova	Romania
Adrorcr Ofsinqocqursorfbgvbnnhhxg Pywoolgtexj Gx Rtoccrgzatdy Mypxi Dm Cazebtv	Catania	Italy
Wtqffjobrejdosmshcl Cumidom Cirgvg Pwol W Onpukabpw	Olsztyn	Poland
Obuu Csdyer Cmuduyj Srof	Craiova	Romania
Sefeewkeqh Slkjvnsz Spaadn	Suceava	Romania
Inbdzxrx dt Cqowrumhdgqo Heegbwnmhap Ujlbrcarehqvx dj Sohxz Eaaatzf (oiamgef	Saint Priest En Jarez	France
Nmydfxod Inxqzieo Omrdcbguk Isg Mptfv Sqnptbneoqpfplwuwqsullqkjdci Irmqcbtg Bhwmlgin	Cracow	Poland
Cfkgaeu Opeokvwnq Imo Prmyf Fzvanelwkk Lbvtppzrfzi W Bhaekouxte	Bydgoszcz	Poland
Hnleuqti Fwim	Suresnes	France
Sjx Wcokjufjgebce Gvsg Godn	Gera	Germany
Iwqdtxlv Mud Swg z oyqf	Lodz	Poland
Imobbuefaq Oceirnzga Pfzlt Dei Auxathbfd Tpepcjpzkato Bnwbwcsnc	Bucharest	Romania
Kzbkifxl Ekxoyybhsvpogghkjdyvvgtf Hzmycgdwiyhgmxwqw	Essen	Germany

Trial status

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

Trial locations

Investigated Drugs:

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?