RecruitingPhase 2NCT04912765

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)


Sponsor

National Cancer Centre, Singapore

Enrollment

60 participants

Start Date

Apr 15, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a personalized cancer vaccine made from a patient's own tumor (a neoantigen dendritic cell vaccine) combined with nivolumab (an immune therapy) helps the immune system fight liver cancer (HCC) or colorectal cancer that has spread to the liver. **You may be eligible if...** - You have liver cancer (HCC) that is manageable with surgery or ablation, with up to 3 tumors or multiple small tumors, and good liver function (Child-Pugh 5 or 6) - OR you have colorectal cancer with liver-only metastases that is potentially removable - You have had recent imaging confirming no disease outside the liver - You are in good enough health for surgery **You may NOT be eligible if...** - Your liver function is severely impaired - Your cancer has spread beyond the liver - You have had serious immune-related side effects from prior immunotherapy - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNeoantigen Dendritic Cell Vaccine

10 doses of the vaccine will be administered via intra-dermal injection concurrently with adjuvant nivolumab.

DRUGNivolumab

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.


Locations(1)

National Cancer Center Singapore

Singapore, Singapore

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NCT04912765


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