Study of BMS-986340, Nivolumab, and Docetaxel for Adults with Advanced or Metastatic Cancer

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What is this study about?

This clinical trial is focused on studying advanced or metastatic cancers, which are cancers that have spread to other parts of the body. The study involves testing a new treatment called BMS-986340, which is being evaluated both on its own and in combination with two other treatments: Nivolumab and Docetaxel. Nivolumab is a medication that helps the immune system fight cancer, while Docetaxel is a chemotherapy drug that works by stopping cancer cells from growing and dividing.

The purpose of the study is to assess the safety and tolerability of BMS-986340 and to determine the best dose to use when given alone or with the other medications. Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how participants respond to the treatment and any side effects they may experience.

This trial is designed for adults aged 18 and older who have advanced or metastatic cancers, including types such as non-small cell lung cancer, head and neck cancer, gastric cancer, and others. The study will help researchers understand how well BMS-986340 works in treating these cancers and whether it can be safely combined with Nivolumab or Docetaxel.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide your consent to participate.

During this visit, a fresh tumor biopsy will be required for biomarker analysis. This is a procedure where a small sample of your tumor is taken for study purposes.

2 screening and eligibility

You will undergo various tests to confirm your eligibility for the trial. These tests will include imaging studies to measure your disease and assess its progression.

Your performance status will be evaluated to ensure you meet the criteria for participation. This involves assessing your ability to perform daily activities.

3 treatment phase

The treatment phase involves receiving the study medications. You may receive BMS-986340 alone or in combination with nivolumab or docetaxel. All medications are administered through an intravenous infusion, which means they are given directly into your vein.

The dosage and frequency of the medications will be determined by the study team based on the specific part of the trial you are participating in. The duration of this phase will depend on your response to the treatment and the study protocol.

4 regular monitoring

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies.

You will be asked to report any side effects or changes in your condition. This information is crucial for assessing the safety and effectiveness of the treatment.

5 follow-up

After completing the treatment phase, you will enter a follow-up period. During this time, the study team will continue to monitor your health and any long-term effects of the treatment.

Follow-up visits will be scheduled at regular intervals as determined by the study protocol.

Who Can Join the Study?

Participants must be 18 years or older and have advanced or metastatic cancers. This means the cancer has spread to other parts of the body.
A fresh tumor sample must be provided before and during treatment for analysis. This is called a biopsy.
The disease must be measurable according to specific criteria, and there must be at least one tumor that can be biopsied.
Participants must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but do not need bed rest during the day.
The disease must have shown progression on or after the most recent therapy, as seen in imaging tests.
Participants must have received standard treatments, including a type of drug known as a programmed death (ligand)-1 inhibitor, unless they are part of a specific group in the study.
Participants must have advanced or metastatic disease and have tried, not be suitable for, or cannot tolerate existing treatments that are known to help their condition.
Eligible cancer types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), gastric or gastroesophageal junction adenocarcinoma, ovarian cancer (OC), triple-negative breast cancer (TNBC), and others as specified in the study.

Who Cannot Join the Study?

Participants must not have any other serious health conditions that could interfere with the study.
Participants should not be pregnant or breastfeeding.
Participants must not have had another cancer treatment within a certain period before the study.
Participants should not have any known allergies to the study drugs.
Participants must not have any active infections that require treatment.
Participants should not have any significant heart problems.
Participants must not have any uncontrolled high blood pressure.
Participants should not have any history of severe lung disease.
Participants must not have any history of severe liver disease.
Participants should not have any history of severe kidney disease.
Participants must not have any history of severe neurological disorders, which are problems with the brain or nerves.
Participants should not have any history of autoimmune diseases, which are conditions where the immune system attacks the body.
Participants must not have participated in another clinical trial recently.
Participants should not have any mental health conditions that could interfere with the study.
Participants must not have any substance abuse issues, such as drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Aancxji Obvtbopcrbp Umcmrrbggffrw Ssvchr	Siena	Italy
Gooeat Uvdfsfftyi Fzeqssohp	Frankfurt	Germany
Unnuipekqypgedmsddrzp Epwzv Are	Essen	Germany
Hbqfovpm Ujpndpjvotfob Hfbkoshy Tequl y Pioxwv Ixogfdyf Cupvle dlaymohnjnyamcadz (osxq	Badalona	Spain
Hegdrloq Vvsq dflnyzke	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.06.2022
Italy	Recruiting	02.06.2022
Spain	Recruiting	02.06.2022

Trial locations

Investigated drugs:

BMS-986340 is an experimental medication being tested to see how safe and tolerable it is for people with advanced solid tumors. This medication is being studied to find out the best dose that can be given safely, either by itself or when used with other treatments. The goal is to understand how it works in the body and if it can help treat cancer.

Nivolumab is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being used in combination with BMS-986340 to see if the two medications together can improve treatment outcomes for people with advanced solid tumors.

Docetaxel is a chemotherapy drug that is used to treat various types of cancer. It works by stopping cancer cells from growing and dividing. In this study, docetaxel is combined with BMS-986340 to determine if this combination can be more effective in treating advanced solid tumors compared to using the medications separately.

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. This stage is also known as metastatic cancer. The progression involves the cancer cells breaking away from the primary tumor and traveling through the bloodstream or lymphatic system to form new tumors in other organs. As the disease progresses, it can affect the function of the organs involved, leading to various symptoms depending on the location of the metastases. The growth and spread of cancer cells can disrupt normal bodily functions and lead to a decline in overall health. The progression rate can vary significantly depending on the type of cancer and individual factors.

Trial ID:

2023-503651-10-00

Protocol code:

CA052-002

NCT ID:

NCT04895709

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of BMS-986340, Nivolumab, and Docetaxel for Adults with Advanced or Metastatic Cancer

What is this study about?

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