Trials / Terminated
TerminatedNCT03071094
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)
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)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Transgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pexastimogene Devacirepvec (Pexa Vec) | 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 |
| DRUG | Nivolumab | Nivolumab will be administered intravenously every 2 weeks (from week 2) |
Timeline
- Start date
- 2017-07-27
- Primary completion
- 2020-09-30
- Completion
- 2021-02-03
- First posted
- 2017-03-06
- Last updated
- 2021-11-19
- Results posted
- 2021-11-19
Locations
2 sites across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03071094. Inclusion in this directory is not an endorsement.