Nivolumab + BMS-986253 for Liver Cancer

Recruiting at 1 trial location

Overseen By Theodore Welling, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must be taking: Antiviral HBV therapy

Must not be taking: Corticosteroids, Immunosuppressives, Statins, others

Disqualifiers: Pregnancy, Other malignancies, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

23 Participants Needed

Trial Summary

What is the purpose of this trial?

A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients.

Research Team

Nina Beri, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I cannot undergo surgery or localized treatments for my condition.

My kidney function is good, with creatinine below 2.0 mg/Dl.

I am a woman who can have children and will take a pregnancy test before starting the study.

Exclusion Criteria

I have lung disease that causes symptoms or could affect lung treatment.

I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

I am currently taking statins.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nivolumab monotherapy or a combination of Nivolumab with BMS-986253 or Cabiralizumab

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986253
• Cabiralizumab
• Nivolumab

Trial Overview The study tests if adding BMS-986253 or Cabiralizumab to Nivolumab improves response rates in HCC patients compared to Nivolumab alone. It's a phase II trial with three groups: one receiving just Nivolumab, and the others each combining it with one of the additional drugs.

Participant Groups

Group I: Nivolumab/Cabiralizumab combination Experimental Treatment 2 Interventions

Group II: Nivolumab/BMS-986253 combination Experimental Treatment 2 Interventions

Group III: Nivolumab Monotherapy Active Control 1 Intervention

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Opdivo for:

• 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

Approved in European Union as Opdivo for:

• 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

Approved in Canada as Opdivo for:

• 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

Approved in Switzerland as Opdivo for:

• 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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+