A 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)

Sponsor
Transgene
Study ID
NCT03071094
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Pexastimogene Devacirepvec (Pexa Vec) — BIOLOGICAL
    Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4
  • Nivolumab — DRUG
    Nivolumab will be administered intravenously every 2 weeks (from week 2)

Study Details

This is a study 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).

Key Dates

Start date
Jul 27, 2017
Status verified
Oct 2021
Primary completion
Sep 30, 2020
Completion
Feb 3, 2021

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pexa-Vec combined with Nivolumab - Phase I
    Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
  • Experimental: Pexa-Vec combined with Nivolumab - Phase IIa
    Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).

Primary Outcome Measure

Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks from the first study drug administration ]

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