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Clinical Trial 19682

Cancer Type: Gastrointestinal Tumor
Interventions:BMS-936558 (Nivolumab); Nivolumab; Placebo

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Richard Kim

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation

Summary

Objective

Primary: To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants. Secondary: To compare overall survival (OS) of nivolumab vs placebo in all randomized participants. To evaluate time to recurrence (TTR) (based on BICR assessment) of nivolumab vs placebo in all randomized participants. Exploratory: 1. To describe the safety and tolerability of nivolumab. 2. To evaluate RFS (based on investigator assessment) of nivolumab vs placebo in all randomized participants. 3. To evaluate time to local recurrence (TLR) (based on BICR assessment) of nivolumab vs placebo in all randomized participants. 4. To evaluate distant metastasis free survival (DMFS) (based on BICR assessments) of nivolumab vs placebo in all randomized participants. 5. To evaluate OS of nivolumab vs placebo in participants who have early (¡Â 1 year) vs late (> 1 year) recurrence. 6. To analyze biomarkers in tumor and peripheral blood to evaluate association with clinical efficacy and/or incidence of AEs. 7. To characterize the pharmacokinetics (PK) of nivolumab in participants with HCC after curative hepatic resection or ablation. 8. To assess the immunogenicity of nivolumab in participants with HCC after curative hepatic resection or ablation. 9. To evaluate the participant¢¯s overall health status using the EQ-5D-3L index and visual analog scale. 10. To evaluate the participant¢¯s cancer-related QoL using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. 11. To describe the healthcare resource utilization (HCRU) in participants with HCC after curative hepatic resection or ablation.

Inclusion Criteria

  • Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
  • Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
  • Child-Pugh Score 5 or 6
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

  • Exclusion Criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Any evidence of tumor metastasis or co-existing malignant disease
  • Participants previously receiving any prior therapy for HCC, including loco-regional therapies
  • Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
  • Other protocol defined inclusion/exclusion criteria could apply