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Clinical Trials/EUCTR2016-000085-32-IT
EUCTR2016-000085-32-IT
Active, not recruiting
Phase 1

A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) - TG6006.01

TRANSGENE SA0 sites55 target enrollmentNovember 4, 2020
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ConditionsHepatocellular carcinomaMedDRA version: 21.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 4 ML- 1 FLACONCINO

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hepatocellular carcinoma
Sponsor
TRANSGENE SA
Enrollment
55
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Male or female patients, age \=18 years old
  • •2\.Histological/cytological diagnosis of primary HCC, excluding cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
  • •3\.Advanced stage HCC per EASL\-EORTC (European Association for the Study of the Liver\-European Organisation for Research and Treatment of Cancer) guidelines, i.e. patients who are not candidates for curative interventions and not candidates for locoregional modalities
  • •4\.Patients naïve to systemic therapy for HCC
  • •5\.Tumor status (as determined by radiology evaluation): At least one measurable viable tumor in the liver, \=1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography \[CT] scan, or dynamic contrast\-enhanced magnetic resonance imaging \[MRI]), and injectable under imaging\-guidance (CT or ultrasound)
  • •6\.At least one tumor that has not received prior local\-regional treatment, or that has exhibited definitive growth of viable tumor since prior local\-regional treatment of HCC undertaken at least 4 weeks prior to enrolment or 3 months prior to enrolment for radioembolization
  • •7\.Child\-Pugh Class A. Note: paracentesis, albumin infusion or diuretic treatment cannot be used to downgrade Child\-Pugh score (e.g., to improve from severe to moderate/mild or from moderate to mild ascites)
  • •8\.Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\.Major surgery within 4 weeks of study treatments (minor surgical procedures are allowed e.g., intravascular access line or Port\-a\-Cath®)
  • •2\.Local\-regional therapy of HCC within 4 weeks or radioembolization within 3 months prior to enrolment
  • •3\.Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma

Outcomes

Primary Outcomes

Not specified

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