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)
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|ClinicalTrials.gov Identifier: NCT03071094|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2017
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Nivolumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||July 27, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
|Experimental: Pexa-Vec combined with Nivolumab||
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
Nivolumab will be administered intravenously every 2 weeks (from week 2)
- Phase I part: To evaluate the safety profile of intratumoral (IT) Pexa-Vec combined with intravenous (IV) nivolumab in patients with advanced HCC. Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ]
DLTs are defined as the occurrence of any of the following events evaluated as related to study drugs and occurring during the first 4 weeks:
- All Grade 3-4 non-hematologic toxicity that represent a 2-grade increase over baseline, excluding: inadequately treated nausea, vomiting and diarrhea, alopecia, transient fatigue and laboratory/metabolic abnormalities.
- Any Grade ≥ 3 treatment-related acute immune-related AE involving major organs.
- Grade ≥ 3 injection site reaction.
- AST or ALT ≥ 10xULN, unless it is related to a definite progression of liver metastases or another clearly identifiable etiology; doubling of AST or ALT that is concurrent with a doubling of the total bilirubin.
- Any toxicity related to study therapy that results in a delay in treatment of 2 or more weeks.
- Neutropenia lasting for more than 7 days; Neutropenic fever; Grade 4 thrombocytopenia or grade 3 thrombocytopenia with clinically significant bleeding.
- Phase IIa part: To evaluate the anti-tumor activity and efficacy of IT Pexa-Vec combined with IV nivolumab in patients with advanced HCC with respect to Overall Response Rate (ORR) (RECIST 1.1). [ Time Frame: 6 months ]Overall response rate (ORR): proportion of patients, whose best overall response is either CR or PR, confirmed at least 4 weeks after initial documentation.
- Disease Control Rate (DCR) at 4 months [ Time Frame: 4 months ]4-month DCR: proportion of patients whose best overall response in the study is either CR, PR, or stable disease (SD) 4 months after D1.
- Overall Survival (OS) [ Time Frame: every 3 months up to 1 year ]Proportion of patients alive at specified time points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071094
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