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

Sponsor
National Cancer Centre, Singapore
Study ID
NCT04912765
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoantigen Dendritic Cell Vaccine — BIOLOGICAL
    10 doses of the vaccine will be administered via intra-dermal injection concurrently with adjuvant nivolumab.
  • Nivolumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Apr 15, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoantigen Dendritic Cell Vaccine and Nivolumab
    NA DC vaccine every 2 weeks at a dose of 3-5 million cells. Adjuvant nivolumab every 2 weeks at 240mg when given concurrently with the vaccine; every 4 weeks at 480mg after vaccine treatment is completed for a total duration of 1 year.

Primary Outcome Measure

24-month Relapse Free Survival [ Time Frame: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years ]

Central Contacts

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