Spots Global Cancer Trial Database for Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

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Trial Identification

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

Official Title: 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)

Study ID: NCT04912765

Conditions

Hepatocellular Carcinoma

Hepatocellular Cancer

Colorectal Cancer

Colorectal Carcinoma

Liver Metastases

Interventions

Neoantigen Dendritic Cell Vaccine

Nivolumab

Study Description

Brief 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.