Study of BMS-986482 alone or with nivolumab, relatlimab or bevacizumab in patients with advanced solid tumors

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What is this study about?

This clinical trial focuses on patients with Advanced Solid Tumors, which are cancers that have spread from where they started to other parts of the body. The study will test a new medication called BMS-986482, both when given alone and in combination with other cancer treatments including nivolumab, relatlimab, and bevacizumab. The main purpose is to determine if BMS-986482 is safe and well-tolerated, and to find the most appropriate dose for future treatment.

During the study, participants will receive BMS-986482 either as tablets taken by mouth, or in combination with other medications that are given through injections under the skin or through an intravenous infusion (a slow drip into a vein). The study includes different groups of patients with various types of advanced cancers, such as non-small cell lung cancer, melanoma, colorectal cancer, breast cancer, and other solid tumors.

The researchers will monitor participants’ health throughout the study to check for any side effects from the treatment. They will also look at how well the medications work together and measure if the tumors respond to the treatment. The study includes regular medical check-ups and imaging tests to track the progress of the disease.

1 Initial assessment

You will undergo screening to confirm that you have an advanced solid tumor that cannot be surgically removed or has spread to other parts of your body.

A tumor tissue sample (biopsy) taken within one month before screening will be required if it is safe to obtain one.

2 Treatment assignment

Based on your specific type of cancer, you will be assigned to receive either:

– BMS-986482 alone as oral tablets

– BMS-986482 combined with nivolumab (given as an injection under the skin)

– BMS-986482 combined with nivolumab and relatlimab (given as an injection under the skin)

– BMS-986482 combined with bevacizumab (given through an infusion into a vein)

3 Treatment period

You will receive the assigned treatment according to a specified schedule.

Regular assessments will be performed to monitor how your tumor responds to the treatment.

Your health status will be closely monitored for any side effects or serious health issues.

4 Follow-up assessments

After completing the treatment, you will have follow-up visits to check your health status.

The study team will continue to monitor any side effects that may occur.

Imaging scans will be performed to assess how your tumor has responded to the treatment.

5 Study completion

The study will continue until May 2029 or until other completion criteria are met.

Your participation may end earlier if your disease progresses or if you experience unacceptable side effects.

Who Can Join the Study?

Must be 18 years or older
Must have an advanced solid tumor that cannot be surgically removed or has spread to other parts of the body (metastatic)
Must be able to provide a tumor tissue sample (biopsy) taken within one month before screening, if it is safe to do so
For initial study parts: may have specific types of cancer including:
- Lung cancer
- Head and neck cancer
- Colorectal cancer (cancer of the large intestine)
- Stomach cancer
- Bladder cancer
- Pancreatic cancer
- Melanoma (skin cancer)
- Breast cancer
For specific study parts (1B1 and 2B1): must have non-small cell lung cancer and specific genetic markers
For lung cancer participants: must have previously received platinum-based chemotherapy and immunotherapy (anti-PD-(L)1 therapy) if eligible
For melanoma study parts: must have previously received melanoma treatments (except eye melanoma, which is not eligible)
For colorectal cancer participants: must have cancer that does not respond to or cannot tolerate standard treatments (fluoropyrimidine and oxaliplatin)
Both men and women may participate

Who Cannot Join the Study?

Previous history of adverse reactions (serious negative effects) to similar medications
Active autoimmune disease (condition where body’s immune system attacks healthy cells) that requires systemic treatment
Untreated brain metastases (cancer that has spread to the brain)
Severe heart conditions including heart failure or uncontrolled high blood pressure
Active or chronic hepatitis B or C infection
Known HIV infection or AIDS
Other active cancer requiring treatment (except for certain skin cancers)
Major surgery within 4 weeks before starting the study
Current participation in other clinical trials
Pregnant or breastfeeding women
Serious organ dysfunction (poor functioning of vital organs like liver, kidneys)
History of organ transplant
Regular use of medications that could interfere with the study drugs
Unable to follow study procedures or attend scheduled visits
Any condition that, in the opinion of the study doctor, makes participation unsafe

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
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Karolinska University Hospital	Solna	Sweden
Rigshospitalet	Copenhagen	Denmark
Netherlands Cancer Institute	Amsterdam	The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Liytr Gklvbnv Hwbeyqku Oz Amdluf	Athens	Greece
Adsvmapdtk Phgjzlxb Hukfcmtq Dc Mxvfbdexi	Marseille	France
Etholda Ulncrtkpqbrx Mtpblht Cnubxvs Rtnnwztny (ekejcex Mxr	Rotterdam	The Netherlands
Hzcstiyk Vwzp dnkpoikn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.10.2025
Denmark	Recruiting	01.10.2025
France	Recruiting	01.10.2025
Greece	Not yet recruiting	01.10.2025
Italy	Recruiting	01.10.2025
Spain	Not yet recruiting	01.10.2025
Sweden	Recruiting	01.10.2025
The Netherlands	Recruiting	01.10.2025

Trial locations

Investigated drugs:

BMS-986482 is an investigational medication being studied for the treatment of advanced solid tumors. This is a new drug that is being tested to understand how safe and effective it is in cancer treatment.

Nivolumab is a medication given as an injection under the skin (subcutaneous). It works by helping your immune system fight cancer cells. It belongs to a group of medicines called immunotherapy drugs.

Relatlimab is an immunotherapy medication that is given in combination with nivolumab as a fixed-dose combination injection under the skin. It helps activate your immune system to fight cancer cells.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that feed tumors. This can help slow down or stop tumor growth. It is commonly used in the treatment of various types of cancer.

Advanced Solid Tumors – A condition where abnormal cells form solid masses or tumors that have spread from their original location to other parts of the body. These tumors can develop in various organs such as the lungs, liver, bones, or brain. The tumors grow by invading nearby tissues and can spread through the bloodstream or lymphatic system. Advanced solid tumors are characterized by continued growth and expansion beyond the initial site. These types of tumors can affect multiple body systems and organs simultaneously.

Trial ID:

2024-516602-28-00

Protocol code:

CA2360001

NCT ID:

NCT06697197

Trial Phase:

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

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Study of BMS-986482 alone or with nivolumab, relatlimab or bevacizumab in patients with advanced solid tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?