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Study of immune response and biomarkers in patients with metastatic solid tumors treated with BMS-986340 and nivolumab

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on patients with advanced cancer that has spread (metastatic solid tumors) including specific types such as Non–Small Cell Lung Cancer, gastric adenocarcinoma, colorectal cancer, and pancreatic adenocarcinoma. These cancers are those that have not responded to certain immune medicines or have not been treated with them before. The treatment being tested combines two intravenous medicines: BMS-986340, an experimental antibody that targets a protein called CCR8, and nivolumab, a known antibody that blocks the PD‑1 pathway used by many cancers to hide from the immune system.

The purpose of the study is to learn how the immune system changes and to find measurable signs (biomarkers) that show whether the tumors are responding when the two drugs are given together, and also to see the early effect of the combination on tumor control. Participants receive a series of IV infusions of the drugs over several weeks while blood and small tissue samples are taken to look at immune cells and other markers; doctors watch for any side effects and track the condition of the cancer through regular scans. Terms such as Treg refer to a type of immune cell that can suppress immune activity, and PD-(L)1–refractory describes tumors that do not respond to treatments that target the PD‑1/PD‑L1 pathway. The study continues until the planned follow‑up period is completed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After joining the study, you will review the study information and sign a consent form that explains the purpose, procedures, risks, and benefits.
Step 2
Baseline assessments
Initial evaluations include a physical examination, blood sample collection, imaging scans of the tumor sites, and optional tissue biopsies to establish a starting point for later comparisons.
Step 3
First treatment infusion
You will receive an intravenous infusion of bms-986340 at a dose of 3 mg, followed by an intravenous infusion of nivolumab at a dose of 480 mg. both medications are administered through a vein in a clinical setting.
Step 4
Subsequent treatment cycles
The same doses of bms-986340 (3 mg) and nivolumab (480 mg) are given by intravenous infusion in each cycle as defined by the study schedule. the interval between cycles and total number of cycles are determined by the protocol.
Step 5
Regular monitoring visits
At each visit you will provide blood samples, undergo imaging scans, and may have additional tissue biopsies to track changes in the tumor and immune response.
Health care staff will record any side effects or adverse events as part of the safety assessment.
Step 6
End-of-treatment evaluation
When the planned treatment period ends, a comprehensive evaluation is performed to determine tumor response using imaging and clinical criteria. this includes assessment of complete response, partial response, or stable disease.
Step 7
Follow-up period
After treatment completion you will continue to attend scheduled visits for additional safety checks and to monitor long-term outcomes.

Who can join the trial?

28 criteria

Be 18 years of age or older, regardless of gender.
Have a life expectancy of more than 12 weeks (about three months).
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Have normal blood‑forming (bone marrow) and organ function, meaning:
- Neutrophils (a type of white blood cell that fights infection) ≥ 1500 per mm³.
- Platelets (cells that help blood clot) ≥ 100,000 per mm³.
- Hemoglobin (protein that carries oxygen in the blood) ≥ 9.0 g/dL.
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  Have kidney function within normal limits, shown by:
  - Serum creatinine (a waste product measured in blood) ≤ 1.5 times the upper normal limit, or
  - Creatinine clearance (an estimate of kidney filtering ability) ≥ 40 mL/min using the Cockcroft‑Gault formula (a standard calculation).
  - Have liver function tests within acceptable ranges:
    
    AST (aspartate aminotransferase) ≤ 2 times the upper normal limit.
    ALT (alanine aminotransferase) ≤ 2 times the upper normal limit.
    Bilirubin (a substance processed by the liver) ≤ 1.5 times the upper normal limit (people with Gilbert syndrome may have bilirubin < 3.0 mg/dL).
    INR (a test of blood clotting) ≤ 1.5 times the upper normal limit.
    PTT (another clotting test) ≤ 1.5 times the upper normal limit.
    Have at least one tumor area that can be safely reached with a core needle biopsy (a small tube used to take a tissue sample), excluding bone lesions.
    Agree to have fresh tumor tissue taken and a small piece of healthy skin removed (skin punch biopsy) before treatment begins (day 1 of cycle 1) and again on the first day of cycles 2 and 3.
    Agree to have a core biopsy of a nearby lymph node that drains the tumor (if it can be reached safely) on the first day of cycles 2 and 3.
    Agree, if possible, to have another fresh tumor biopsy, skin punch biopsy, and lymph‑node biopsy on the first day of cycle 5.
    Agree, if possible, to have a fresh tumor biopsy taken if the cancer gets worse (progresses).
    Have a tumor that can be biopsied with an acceptable level of clinical risk, as judged by the doctor. If the first biopsy attempt does not obtain enough tissue, a second attempt may be made.
    Be able to understand the study information and sign a written informed consent form approved by an ethics board (IRB), or have a legally authorized representative do so.
    If you are a woman who could become pregnant, you must provide proof that you are not able to become pregnant, or you must have a negative pregnancy test (blood or urine) within 24 hours before starting treatment and agree to have a pregnancy test on the first day of each treatment cycle. You must also use a highly effective method of birth control (failure rate < 1 % per year) during treatment and for at least 3 months after the last single‑drug dose or 6 months after the last combination dose, and you must not donate eggs during that time.
    If you are a man, you do not need to use any specific birth‑control method, but you should continue any usual practice you follow.
    Have a confirmed diagnosis (by looking at the tumor cells under a microscope) of one of the following cancers: non‑small cell lung cancer, gastric (stomach) cancer, microsatellite‑stable colorectal cancer, or pancreatic adenocarcinoma.
    Have already received all standard treatments that are normally available for your cancer, including any approved PD‑(L)1 inhibitors if they are known to work for your tumor type, and have no other approved or effective treatment options left.
    For lung or stomach cancer groups, you must have already tried at least one treatment that included a PD‑(L)1 drug and it must not have worked.
    For colorectal or pancreatic cancer groups, you must have tried at least one standard chemotherapy regimen (for example, FOLFOX/FOLFIRI for colorectal cancer or gemcitabine/nab‑paclitaxel for pancreatic cancer), have not received any immunotherapy before, and have no further standard options that improve survival.
    Have cancer that is getting larger or spreading, as shown by imaging tests (radiographically documented progressive disease) after the most recent therapy.
    Have measurable disease according to RECIST 1.1 criteria (a standard way doctors measure tumor size and response).
    Have an ECOG performance status of 0 or 1 (meaning you are fully active or limited in physically strenuous activity but can carry out light work) or a Karnofsky performance status of 70 % or higher (meaning you can care for yourself but may not be able to do normal activities).

Who cannot join the trial?

13 criteria

Having an active autoimmune disease (where the body’s immune system mistakenly attacks its own tissues).
Having serious heart or cardiovascular problems in the past 6 months, such as a heart attack, fluid around the heart, heart muscle inflammation, irregular heart rhythm (like atrial fibrillation), moderate or worse heart failure, a prolonged QT interval on an ECG (over 470 ms), uncontrolled high blood pressure, or unstable chest pain (angina).
Having active diverticular disease or uncontrolled inflammatory bowel disease (IBD) (persistent inflammation of the intestines).
Having another invasive cancer that required treatment (other than surgery alone) within the last 2 years.
Having mental impairment that makes it difficult to understand the study information or follow study requirements.
Having stopped a previous immunotherapy because of severe immune‑related side effects.
Having untreated or unstable cancer that has spread to the brain or spinal cord, including leptomeningeal (covering of the brain) spread.
Having any serious or uncontrolled medical condition that the doctor believes would increase the risk of participating or could affect the study results.
Receiving any anticancer treatment (such as chemotherapy, radiation therapy, or immunotherapy) within 14 days before starting the study medication.
Taking steroids (for example, prednisone) at a dose higher than 10 mg per day.
Having a known primary immunodeficiency (a genetic problem with the immune system) or active HIV infection.
Being pregnant or having a positive pregnancy test.
Having active or chronic hepatitis B or hepatitis C infection, as shown by a positive blood test for the virus.

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IRCCS Humanitas Research Hospital
Rozzano, Italy

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Investigated drugs

Anti‑CCR8 NF mAb (BMS‑986340)
is an experimental antibody that is given by IV infusion. It is designed to attach to a protein called CCR8 that is found on certain immune cells called regulatory T cells (Tregs). By binding to CCR8, the antibody helps reduce the number of these Tregs, which can otherwise suppress the body’s ability to fight cancer. In this trial the drug is tested both by itself and together with another immunotherapy to see how removing Tregs affects tumor response.
Nivolumab (OPDIVO)
is a widely used immunotherapy drug that is also given by IV infusion. It works by blocking a checkpoint protein called PD‑1 on immune cells, which normally tells the immune system to slow down. By inhibiting PD‑1, nivolumab helps the immune system stay active and better recognize and attack cancer cells. In the study it is combined with the anti‑CCR8 antibody to see if the two drugs together improve anti‑tumor activity.

What is already known about the treatment

BMS-986340
This experimental drug is supplied as a sterile solution for injection and is given by slow intravenous infusion, typically at a dose of 3 mg. It is still in clinical trials and has not yet received regulatory approval, so information about it is limited to recent study reports. The antibody is being tested for use in patients with metastatic solid tumors that have not responded to other immunotherapies. It works by attaching to the CCR8 protein on certain immune cells, reducing their suppressive activity and helping the body’s own defenses attack cancer, and it is classified as a monoclonal antibody that targets regulatory T‑cell pathways.
Nivolumab
Nivolumab comes as a concentrate that is mixed with fluid and delivered by intravenous infusion, usually 480 mg per dose. It is an approved cancer medicine that has been studied extensively and is listed in medical guidelines and literature worldwide. The drug is used to treat a range of advanced cancers, including non‑small cell lung cancer, gastric, colorectal (microsatellite stable) and pancreatic tumors. It blocks the PD‑1 protein on immune cells, preventing the tumor from turning off the immune response, and it is classified as a monoclonal antibody that inhibits the PD‑1 checkpoint.

Investigated diseases

Non‑small cell lung cancer
A type of lung cancer that starts in the cells lining the airways. When cancer cells spread to other parts of the body, it becomes metastatic non‑small cell lung cancer. The disease may grow slowly at first, but cancer cells can travel through blood or lymph to distant organs. New tumor sites develop as the disease progresses, leading to increasing symptoms.
Gastric adenocarcinoma
A cancer that begins in the glandular cells of the stomach lining. When cancer cells break away and travel to other organs, it is called metastatic gastric adenocarcinoma. The tumor often enlarges and may invade nearby tissues before spreading. Metastatic spread leads to new tumors in the liver, peritoneum, or other sites, and the disease gradually advances.
Colorectal cancer
A malignancy that starts in the colon or rectum. When cancer cells spread to distant sites, it is referred to as metastatic colorectal cancer. The primary tumor can grow and invade the wall of the colon, then cancer cells enter blood vessels or lymph nodes. These cells travel and form new tumors in organs such as the liver or lungs, increasing the number of affected sites over time.
Pancreatic adenocarcinoma
A cancer that originates in the exocrine cells of the pancreas. Once cancer cells spread beyond the pancreas, the condition is called metastatic pancreatic adenocarcinoma. The tumor can grow within the pancreas and infiltrate surrounding tissues before entering the bloodstream. Cancer cells then establish secondary tumors in the liver, lungs, or other organs, and the disease advances as more sites become involved.