Nivolumab + BMS-986253 for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining different treatments with Nivolumab can improve outcomes for people with advanced liver cancer. Researchers are testing two combinations: Nivolumab with BMS-986253 (an experimental treatment) and Nivolumab with Cabiralizumab, compared to Nivolumab alone. The goal is to assess whether these combinations lead to better responses in imaging tests that track cancer progression. Suitable participants have advanced liver cancer confirmed through a biopsy (a small tissue sample) and are not eligible for surgery or other local treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot use statins or certain herbal supplements, and you must not be on other investigational agents or systemic therapies before joining. If you have hepatitis B, you must continue anti-viral therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both combinations tested in this trial—Nivolumab with BMS-986253 and Nivolumab with Cabiralizumab—have been safe in earlier studies for other conditions.
For the Nivolumab and BMS-986253 combination, earlier studies indicate it is generally well-tolerated, with no major safety issues reported. Some patients experienced mild side effects, which were manageable.
For Nivolumab and Cabiralizumab, studies also suggest this combination is safe. Most side effects were mild, such as fatigue or minor skin reactions.
Nivolumab is already approved for other types of cancer, which adds confidence about its safety. However, discussing these results with a healthcare provider is advisable to understand their personal implications.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they represent new approaches in tackling liver cancer. Nivolumab is an immunotherapy that works by enhancing the body's own immune response to target and destroy cancer cells, differing from traditional chemotherapy that directly kills cancer cells but also harms healthy cells. The combination therapies, Nivolumab with BMS-986253 and Nivolumab with Cabiralizumab, are designed to potentially boost this immune response even further. BMS-986253 is an anti-IL-8 antibody that may reduce inflammation in the tumor environment, while Cabiralizumab targets the CSF-1 receptor, potentially disrupting signals that help tumors evade the immune system. These innovative combinations offer hope for more effective treatments with potentially fewer side effects compared to standard options like sorafenib or lenvatinib.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research has shown that combining nivolumab with BMS-986253, one of the treatment options in this trial, might help liver cancer patients by enhancing their immune system's ability to fight cancer. Early studies suggest this combination works by blocking interleukin-8, a protein that aids tumor growth. Another treatment arm in this trial tests nivolumab with cabiralizumab for its potential to reduce tumor-associated macrophages, immune cells that can help tumors evade the immune system. Although these combinations remain under study, initial results suggest they could enhance the effectiveness of immunotherapy for advanced liver cancer.12456
Who Is on the Research Team?
Nina Beri, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adults with advanced liver cancer (HCC) who haven't had other systemic treatments. They must have a Childs-Pugh score ≤7, adequate organ function, and no history of certain conditions like tuberculosis or uncontrolled heart disease. Participants need to agree to contraception methods if applicable and can't be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Nivolumab monotherapy or a combination of Nivolumab with BMS-986253 or Cabiralizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986253
- Cabiralizumab
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor