Health TrialsbyHealthPanel

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

ConditionsHepatocellular CarcinomaHepatocellular CancerColorectal CancerColorectal CarcinomaLiver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Cancer Centre, Singapore

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have either newly diagnosed or recurrent HCC, confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic subjects amenable for management with curative intent by resection (with or without the addition of local ablation), if they fulfil the following radiological criteria.

Up to three tumours, at least one with a diameter > 3cm

More than three tumours, none with a diameter > 5 cm

Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)

Disqualifiers

Target Disease Exceptions

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

Any evidence of tumour metastasis or co-existing malignant disease.

Participants showing evidence of macrovascular invasion on imaging tests.

Trial design

Design model

Single group

Treatments tested in this trial

  • Neoantigen Dendritic Cell Vaccine

    Biological/Vaccine

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Neoantigen Dendritic Cell Vaccine and NivolumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

24-month Relapse Free Survival

To investigate the clinical efficacy of combining NA DC vaccine with nivolumab in resected HCC and resected CRLM patients.

Time frame
Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years
2

Induced immune response against vaccinated NAs

To determine the presence of NA specific T cells in resected HCC and resected CRLM patients after vaccination. Assessed by EPISOT and/or intracellular cytokine staining (ICS) assay with NA peptides in post-vaccination peripheral blood mononuclear cells (PBMC) compared to pre-vaccination PBMCs.

Time frame
Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years

Secondary outcomes

1

Frequency and severity of treatment-emergent adverse events (AE)

To determine the safety and tolerability of combining NA DC vaccine and nivolumab

Time frame
From the time of start of first treatment administered until 100 days after last dose of study treatment
2

Overall Survival

Time frame
From time of start of study enrolment to death due to any cause, up to 7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Centre, Singapore

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
Apply now