Study of BMS-986253 with Nivolumab and Ipilimumab for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced cancers, specifically those with advanced solid tumors. The study involves the use of an experimental medication called BMS-986253, which is being tested in combination with other medications, namely Nivolumab and Ipilimumab. These medications are administered as a solution through an intravenous infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to explore the safety and effectiveness of these combinations in treating advanced cancers. The study is divided into two parts. In the first part, the focus is on understanding how safe and tolerable the combination of BMS-986253 with Nivolumab, or with both Nivolumab and Ipilimumab, is for patients. The second part of the study aims to compare the effects of the combination of BMS-986253, Nivolumab, and Ipilimumab with a placebo plus Nivolumab and Ipilimumab in patients with advanced melanoma, a type of skin cancer, who have a specific level of a protein called IL-8 in their blood.

Throughout the study, participants will receive the treatments and be monitored for any side effects or changes in their condition. The study will help determine the best dose of BMS-986253 when used with these other medications and will provide valuable information on how these treatments can help manage advanced cancers. The study is expected to continue until mid-2025, providing insights into the potential benefits and risks of these treatment combinations for patients with advanced cancers.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of at least one lesion accessible for biopsy and an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

2 treatment phase 1

In the first part of the treatment, the focus is on evaluating the safety and tolerability of the medications. The medications used include nivolumab and ipilimumab, both administered intravenously as a solution for infusion.

The dosage and frequency are determined based on the specific protocol of the study. The goal is to identify any dose-limiting toxicities and establish the recommended dose for further study.

3 treatment phase 2

In the second part of the treatment, the effectiveness of the medication combination is compared to a placebo. This phase involves the use of BMS-986253 in combination with nivolumab and ipilimumab.

The objective is to assess progression-free survival in patients with advanced melanoma and specific serum levels of IL-8.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track any adverse events, serious adverse events, and any changes in clinical laboratory results.

The study also evaluates the progression-free survival and overall survival of participants, using specific criteria to assess the response to treatment.

5 completion and analysis

Upon completion of the trial, data is analyzed to determine the overall safety and effectiveness of the treatment. This includes reviewing the incidence of adverse events and the overall survival rates of participants.

Who Can Join the Study?

Participants must have advanced solid tumors. This means the cancer has spread and is not limited to one area.
Participants need to have at least one lesion that can be accessed for a biopsy. A lesion is an area of abnormal tissue, and a biopsy is a procedure to take a small sample of tissue for testing.
Participants should have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Participants with non-small cell lung carcinoma (a type of lung cancer) are eligible only for specific parts of the study.
Participants must be within certain age ranges, which are typically defined in the study.
Both male and female participants are eligible to join the study.
The study may include individuals from vulnerable populations, which means people who might need special protection or consideration.

Who Cannot Join the Study?

Patients who have not fully recovered from previous treatments or surgeries.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with known allergies to the study medications.
Patients with certain infections that are not well controlled.
Patients with a history of certain heart conditions.
Patients who are unable to follow the study procedures.

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
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Universitair Ziekenhuis Gent	Gent	Belgium
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ufzkvgeogv Mrcreha Cycsrx Hqtfndsohwyavvruv	Hamburg	Germany
Cduurfbkg Ubzlwyfxdazywf Sbgwybxbw	Woluwe-Saint-Lambert	Belgium
Ibhfroba Rnafqlsqn Ptq Lu Scpkyr Dma Tqmcip Durx Ajvbnqf Ihrz Sqshbt	Meldola	Italy
Aaodmnazju Pztcohpr Hgalewwd Do Mmcrwccib	Marseille	France
Nnuokuak Icfbsreq Oceoktzjd Ivf Mgdye Ssznzyrbmekuglnfxftezgcuxhpb Irtafsvg Bvhfdbhi	Cracow	Poland
Hjssdiwk Vxma dmluuunk	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.02.2018
France	Not recruiting	12.02.2018
Germany	Not recruiting	12.02.2018
Italy	Not recruiting	12.02.2018
Poland	Not recruiting	12.02.2018
Spain	Not recruiting	12.02.2018

Trial locations

Investigated drugs:

BMS-986253 is an experimental medication being studied for its potential to treat advanced cancers. It is being tested to see how safe and tolerable it is when used in combination with other cancer treatments. Researchers are also trying to find the best dose to use in future studies.

Nivolumab is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this study, it is being used in combination with other treatments to see if it can improve outcomes for patients with advanced cancers.

Ipilimumab is another medication that helps the immune system attack cancer cells. It works by targeting a different protein than nivolumab, and it is often used in combination with other treatments to enhance the immune response against cancer. In this trial, it is being combined with nivolumab and BMS-986253 to evaluate its effectiveness in treating advanced cancers.

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body. The progression of these tumors can lead to a range of symptoms depending on their location and size, such as pain, swelling, or organ dysfunction. The complexity of advanced solid tumors often requires comprehensive management to address the challenges they present.

Trial ID:

2023-509061-20-00

Protocol code:

CA027-002

NCT ID:

NCT03400332

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of BMS-986253 with Nivolumab and Ipilimumab for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?