Study of BMS-986442 and Nivolumab, Alone or with Chemotherapy, for Patients with Advanced Solid Tumors and Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for people with advanced solid tumors and non-small cell lung cancer. The study involves a new treatment called BMS-986442, which will be tested in combination with another medication called nivolumab. In some cases, these medications will also be combined with chemotherapy drugs such as docetaxel, paclitaxel, carboplatin, and pemetrexed disodium. The purpose of the study is to understand how safe and tolerable these combinations are for patients.

Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several phases, starting with a smaller group of participants to determine the best dose and then expanding to a larger group to further assess the treatment’s effects. Throughout the study, researchers will monitor participants closely to observe any side effects and how well the treatment works against the cancer.

The study aims to gather important information about the new treatment’s safety and how it interacts with the body. This includes looking at how the body processes the medication and any potential immune responses. The study will also evaluate the treatment’s effectiveness in controlling the cancer over time. This research is crucial for developing new therapies that could improve outcomes for people with these types of cancer.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking if you have a measurable disease and an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which indicates your ability to perform daily activities. Your life expectancy should be at least 3 months.

3 treatment phase

During the treatment phase, you will receive medications through an intravenous (IV) infusion. The medications include docetaxel, nivolumab, paclitaxel, bms-986442, carboplatin, and pemetrexed disodium. The specific combination and dosage will depend on the study group you are assigned to.

The frequency and duration of administration will be explained to you by the study team. Regular monitoring will be conducted to assess the safety and effectiveness of the treatment.

4 monitoring and follow-up

Throughout the trial, you will be monitored for any side effects or adverse events. This includes regular check-ups and tests to ensure your safety. The study aims to identify any adverse effects and determine the maximum tolerated dose of the medications.

You will also be evaluated for the treatment’s effectiveness in managing your condition. This involves measuring the response of your disease to the treatment over time.

5 completion of the trial

At the end of the trial, a final assessment will be conducted. This includes a review of your overall health and the outcomes of the treatment.

You will receive information about any further steps or follow-up care that may be necessary after the trial concludes.

Who Can Join the Study?

Participants must have a measurable disease according to specific criteria used by doctors to assess tumors.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means they should be fully active or have some symptoms but can still carry out light work.
Participants must have a life expectancy of at least 3 months at the time of the first dose.
Participants can be of any gender.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Alzovqy Ogyctaanquh Ueseoxrfclyza Sngzpa	Siena	Italy
Udiqbsoyltgyqi Chignpr Koxiymdoo	Gdansk	Poland
Hxajhcpb Vaql dtaeyujs	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.08.2023
Poland	Not recruiting	01.08.2023
Spain	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

BMS-986442 is an experimental medication being tested to see how safe it is and how well it works when used with other treatments. It is not yet approved for general use, and researchers are studying it to understand its effects on advanced solid tumors and non-small cell lung cancer. This medication is being tested to find the best dose that can be given safely to patients.

Nivolumab is a type of cancer treatment known as immunotherapy. It works by helping the body’s immune system recognize and attack cancer cells. Nivolumab is already used to treat various types of cancer, and in this trial, it is being combined with other treatments to see if it can improve outcomes for patients with advanced solid tumors and non-small cell lung cancer.

Chemotherapy refers to a group of cancer-fighting drugs that work by killing rapidly dividing cells, which include cancer cells. In this trial, chemotherapy is used alongside other treatments to see if it can help improve the effectiveness of the overall treatment plan for patients with advanced solid tumors and non-small cell lung cancer.

Investigated diseases:

Solid Tumor – A solid tumor is an abnormal mass of tissue that usually does not contain cysts or liquid areas. These tumors can occur in various parts of the body, including organs, muscles, and bones. They are characterized by the uncontrolled growth of cells that form a lump or mass. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they can invade nearby tissues and spread to other areas. The progression of solid tumors depends on their type, location, and whether they are benign or malignant. Malignant solid tumors may grow rapidly and invade surrounding tissues, potentially spreading to distant parts of the body.

Non-small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for a majority of cases. NSCLC typically starts in the tissues of the lungs and can grow and spread to other parts of the body. The progression of NSCLC can vary, with some tumors growing slowly and others more rapidly. As the cancer advances, it may invade nearby tissues and organs, and potentially spread to distant sites through the bloodstream or lymphatic system. The rate of progression and spread depends on various factors, including the specific subtype and stage of the cancer.

Trial ID:

2022-503108-26-00

Protocol code:

CA115-001

Trial Phase:

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

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Study of BMS-986442 and Nivolumab, Alone or with Chemotherapy, for Patients with Advanced Solid Tumors and Non-Small Cell Lung Cancer

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