Study of BMS-986288 and Nivolumab for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying advanced solid cancers, which include various types such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, cutaneous melanoma, triple-negative breast cancer, renal cell carcinoma, urothelial carcinoma, and cancers of the stomach, esophagus, cervix, and colon. The study is investigating a new treatment called BMS-986288, which is being tested both on its own and in combination with another medication called Nivolumab. Additionally, the study will compare the combination of BMS-986288 and Nivolumab with a medication called Regorafenib in certain cases of colon cancer.

The purpose of this study is to understand the safety and tolerability of BMS-986288, as well as to find the best dose to use when given alone or with Nivolumab. The study will also look at how effective the combination of BMS-986288 and Nivolumab is compared to Regorafenib in treating colon cancer. Participants in the study will receive the treatments through either an injection or as tablets, depending on the medication being tested. The study will monitor participants for any side effects and how well the cancer responds to the treatment.

This trial is divided into different parts, with each part focusing on specific goals. In the initial phases, the study will focus on determining the safest dose of BMS-986288. Later phases will compare the effectiveness of the combination treatment against Regorafenib. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatments affect their cancer. The study aims to provide valuable insights into new treatment options for people with advanced solid cancers.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A biopsy may be performed to confirm the presence of advanced solid tumors, such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, or other specified cancers.

2 treatment plan discussion

The treatment plan is discussed, including the medications involved in the study. These include BMS-986288, nivolumab, and regorafenib.

The method of administration is explained: BMS-986288 and nivolumab are given through an intravenous infusion, while regorafenib is taken orally as a tablet.

3 treatment initiation

The treatment begins with the administration of BMS-986288 alone or in combination with nivolumab. The dosage and frequency are determined based on the study phase and individual response.

For some participants, regorafenib may be administered as a comparison treatment in later stages of the study.

4 regular monitoring

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests, imaging studies, and physical examinations.

Participants are observed for any side effects or adverse reactions to the medications.

5 dose adjustment

Based on the monitoring results, the dosage of BMS-986288 and nivolumab may be adjusted to find the most effective and safe dose.

The goal is to determine the maximum tolerated dose and the recommended dose for future studies.

6 follow-up assessments

Follow-up assessments are conducted to evaluate the response to treatment. This includes measuring tumor size and progression.

The duration of response and overall survival rates are also assessed to determine the treatment’s effectiveness.

7 end of study participation

At the end of the study, a final assessment is conducted to gather comprehensive data on the treatment’s impact.

Participants may receive guidance on further treatment options based on their response to the study medications.

Who Can Join the Study?

  • Must have a confirmed diagnosis of a specific type of advanced solid tumor. This means the cancer is in a late stage and may have spread to other parts of the body. The types of cancer include squamous cell carcinoma of the head and neck, non-small cell lung cancer, cutaneous melanoma, triple-negative breast cancer, renal cell carcinoma, urothelial carcinoma, gastric, esophageal, cervical, and colorectal cancer.
  • Must have at least one tumor that can be measured and is accessible for a biopsy. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined more closely.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Must have previously received at least one standard treatment for their advanced or metastatic cancer and either did not respond to it, the cancer came back, or they could not tolerate the treatment.
  • Both male and female participants are eligible.
  • Participants must be within the specified age range for the study.

Who Cannot Join the Study?

  • Patients with any other type of cancer not listed in the study.
  • Patients who have had a severe allergic reaction to similar medications in the past.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments within a specific time frame before the study.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Aywgamoepz Pnsyhelf Hrawdszu Dn Mfghhgqas Marseille France
Hgavhnkl Vnwn dyiebhyk Barcelona Spain
Itcpujkp Cabjr Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
16.06.2022
Italy Italy
Not recruiting
16.06.2022
Spain Spain
Not recruiting
16.06.2022

Trial locations

BMS-986288 is an experimental medication being tested to see how safe and tolerable it is for people with advanced cancer. Researchers are trying to find out the best dose that can be given without causing too many side effects. This medication is being studied both on its own and in combination with another drug to see how well it works against cancer.

Nivolumab is a medication that helps the immune system fight cancer. It works by blocking a specific protein that usually stops the immune system from attacking cancer cells. By blocking this protein, nivolumab allows the immune system to better recognize and destroy cancer cells. In this trial, it is being used in combination with another experimental drug to see if they work better together.

Regorafenib is a medication used to treat certain types of cancer by blocking proteins that help cancer cells grow and spread. It is already approved for use in some cancers, and in this trial, it is being compared to a combination of other drugs to see which treatment is more effective for patients with a specific type of advanced cancer.

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck. It typically begins as a small, painless lump or sore that does not heal. Over time, it can grow and invade nearby tissues, potentially causing symptoms like difficulty swallowing or changes in voice. The disease can spread to lymph nodes in the neck and, in advanced stages, to other parts of the body.

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It generally starts in the tissues of the lungs and can grow slowly or rapidly, depending on the subtype. As it progresses, it may cause symptoms such as persistent cough, chest pain, and shortness of breath. The cancer can spread to other parts of the body, including the brain and bones.

Cutaneous Melanoma – This is a form of skin cancer that develops in the melanocytes, the cells responsible for skin pigment. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. Melanoma can grow quickly and has the potential to spread to other parts of the body, including the lymph nodes and internal organs.

Triple-Negative Breast Cancer – This is a subtype of breast cancer that lacks three common receptors known to fuel most breast cancer growth. It tends to be more aggressive and is more likely to spread and recur compared to other breast cancer types. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling.

Renal Cell Carcinoma – This is the most common type of kidney cancer in adults, originating in the lining of the small tubes in the kidney. It often grows as a single mass within the kidney but can also occur in more than one part of the kidney. As it progresses, it may cause symptoms such as blood in the urine, back pain, and weight loss.

Urothelial Carcinoma – This cancer begins in the urothelial cells that line the bladder and other parts of the urinary tract. It often presents with symptoms like blood in the urine and frequent urination. The disease can invade deeper layers of the bladder wall and spread to nearby organs and lymph nodes.

Gastric Cancer – Also known as stomach cancer, this disease starts in the stomach lining and can grow to form a tumor. It may cause symptoms such as indigestion, stomach pain, and nausea. As it advances, it can spread to nearby organs and lymph nodes.

Esophageal Cancer – This cancer occurs in the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the esophagus and can cause symptoms like difficulty swallowing and chest pain. The cancer can grow to block the esophagus and spread to other parts of the body.

Cervical Cancer – This type of cancer starts in the cells of the cervix, the lower part of the uterus that connects to the vagina. It often develops slowly, beginning as a precancerous condition called dysplasia. As it progresses, it can cause symptoms such as abnormal vaginal bleeding and pelvic pain.

Colorectal Cancer – This cancer affects the colon or rectum and often begins as a growth called a polyp on the inner lining. Over time, some polyps can turn into cancer, which can then invade the wall of the colon or rectum. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.

Trial ID:
2023-508954-25-00
Protocol code:
CA043-001
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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