Nivolumab + BMS-986253 for Liver Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byNina Beri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

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.

See 14 more

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.

See 18 more

Treatment Details

Interventions

BMS-986253 (Unknown)
Cabiralizumab (Monoclonal Antibodies)
Nivolumab (Monoclonal Antibodies)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab/Cabiralizumab combinationExperimental Treatment2 Interventions

Group II: Nivolumab/BMS-986253 combinationExperimental Treatment2 Interventions

Group III: Nivolumab MonotherapyActive Control1 Intervention

Nivolumab is already approved in Canada, Switzerland for the following indications: