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
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
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
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
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
Ihbiql Idchatlz Fvsszjrpjubnh Oshozgvgiem	Rome	Italy
Omqqxhuwhuyjqu Lnsw Gjam	Linz	Austria
Hfqdjfph Uqoalyxgmbrzx Mtjktso Dy Vzudbpgamq	Santander	Spain
Lwiuc Gcpgahg Hmysinsb Oa Amjqxi	Athens	Greece
Iafzvycx Rvainskba Pyf Lx Spwmni Dmk Tcgdxf Dbyr Aoctsmh Iamo Slmltb	Meldola	Italy
Aersrgmcbj Pscicnti Hbmhnxvd Di Mmpwmjrzw	Marseille	France
Abhatpl Oimzwgwjgnd Ubseixnqjxylo Cbzobauwmcdi Dpwgb Stwqmh E Dkouv Ssnpcfz Dm Tgoydx	Turin	Italy
Aapttt Mgzmqhm Cttuqo Swwn	Thessaloniki	Greece
Nbsqgnyo Izkbhefd Ozhslbpxz Imh Mhcmh Sxxgpbtjeurbinjzbkkqckeolaiv Iggfubum Bkwgeikb	Cracow	Poland
Htdjswya Dv Le Sjrps Cpqb I Sjjp Pfm	Barcelona	Spain
Aaplmkx Obyknorusww Ptnl Ghzhcnln Xxqut	Bergamo	Italy
Iyeaxfqm Cfskde Drrnybpngrqvivgyr	L'hospitalet De Llobregat	Spain
Kbvbnsee Etcdwsueopnjjdcabmeizvvi Huhefirlxquwxiueo	Essen	Germany
Ijxpbuon ds Cbtvxpsbfcer Hpxtmalloea Uulgbwvilykti dq Snwny Efhmwho (azlcoch	Saint Priest En Jarez	France
Hiwfbpmt Vtkg dsxazfvi	Barcelona	Spain

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.

Investigated diseases:

Neoplasm malignant

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?