NCT04912765

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

An Open Label, Single-arm, Phase II Neoantigen (NA) Dendritic Cell (DC) Vaccine and Anti-PD1 (Nivolumab) as Adjuvant Treatment in Resected Hepatocellular Carcinoma (HCC) (Group A) and Liver Metastases From Colorectal Cancer (CRLM) (Group B)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with/without local ablation).

Detailed description

Participants will be consented prior to resection of HCC and CRLM. Genomic sequencing of patient's blood and resected tumour will be performed, followed by tumour NA prediction and production. Patients will undergo venesection to generate DCs which will be pulsed with autologous NAs to produce the vaccine. 10 dose of intra-dermal NA DC vaccine will be administered every 2 weeks together with IV nivolumab (starting from the second vaccine dose). Patients will subsequently continue on adjuvant nivolumab to complete 1 year of treatment. Efficacy will be evaluated based on relapse-free survival (RFS) at 24 months from surgery and the analyses of specific anti-NA immune responses of autologous peripheral T cells by ELISPOT and/or ICS assays. Safety data will also be obtained for patients who have received at least one dose of treatment.

Conditions

• Hepatocellular Carcinoma
• Hepatocellular Cancer
• Colorectal Cancer
• Colorectal Carcinoma
• Liver Metastases

Interventions

Type	Name	Description
BIOLOGICAL	Neoantigen Dendritic Cell Vaccine	10 doses of the vaccine will be administered via intra-dermal injection concurrently with adjuvant nivolumab.
DRUG	Nivolumab	9 doses of 240mg IV nivolumab as a 30 minutes infusion will be administered in combination with NA DC vaccine starting from the second vaccine dose. Upon completion of 10 doses of NA DC vaccine, 480mg IV nivolumab will be administered as a 30 minutes infusion for a maximum of 9 doses.

Timeline

• Start date: 2021-04-15
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2021-06-03
• Last updated: 2025-09-23

Locations

1 site across 1 country: Singapore