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ACTIVE NOT RECRUITING
NCT04658147
PHASE1

Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and feasibility of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.

Official title: Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2021-05-28

Completion Date

2030-06-01

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

Patients received 480mg Nivolumab as a 30 minute IV infusion on Day 1 of Cycles 1 and 2 (28 day cycles) prior to surgery. Post-surgery, patients received an additional 10 doses of adjuvant 480mg Nivolumab therapy on Day 1 of each cycle (every 28 days).

DRUG

Relatlimab

Patients received either 480mg or 960mg Relatlimab as a 30 minute IV infusion on Day 1 of Cycles 1 and 2 (28 day cycles) prior to surgery. Post-surgery, patients received an additional 10 doses of adjuvant 480mg or 960mg Relatlimab therapy on Day 1 every 28 days. Dosing was changed from 960mg to 480mg based on guidance from Bristol Myers Squibb.

Locations (2)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

The Ohio State University, Wexner Medical Center

Columbus, Ohio, United States