Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer

Detailed description public domain (ClinicalTrials.gov)

Multi-center, open label, randomized, 2-parallel arm, phase IIb study of nab-paclitaxel and gemcitabine as Standard of Care (SoC) plus/minus VCN-01 in patients with metastatic pancreatic cancer. Gemcitabine and nab-paclitaxel are chemotherapy drugs approved by the FDA to treat pancreatic cancer. VCN-01 is a genetically modified adenovirus characterized by the presence of four independent genetic modifications in the backbone of the wild-type human adenovirus serotype 5 (HAd5) genome that confer tumor selective replication and antitumor activity. Approximately 92 patients in sites in North America and European Union (EU) will be recruited and randomized in a 1:1 ratio to one of two treatment arms (i.e., approximately 46 patients per treatment arm): * Arm 1- (SoC): Nab-paclitaxel and gemcitabine as SoC (28-day cycles). Patients in this arm will not receive the investigational medicinal product (IMP) VCN-01. * Arm 2- (VCN-01+ SoC): A maximum of two (2) doses of VCN-01 administrated in combination with nab-paclitaxel and gemcitabine as SoC (28-day cycles with exception of the IMP dose cycles, which will be 35-day cycles). A Data Monitoring Committee (DMC) will be convened at regular intervals to assess safety and to look at OS to determine if the trial can continue.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival [From date of randomization until the date of death from any cause, assessed up to 27 months]. Median, months (95% Confidence Interval). Arm 1-SoC (n=48): 8.6 (6.9 to 11.6); Arm 2 -VCN-01 + SoC (n=48): 10.8 (7.4 to 15.8).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of TEAEs in Each Treatment Arm [until the end of treatment period phase]. Number, number of TEAEs in each treatment arm. Arm 1-SoC (n=48): 299; Arm 2 -VCN-01 + SoC (n=53): 399.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Progression (TTP) or Progression Free Survival (PFS) [TTP: From randomization until documented disease progression assessed up to 27 months. PFS: From randomization to either progression or death from any cause assessed up to 27 months.]. Median, months (95% Confidence Interval). Arm 1-SoC (n=48): 4.6 (3.5 to 6.5); Arm 2 -VCN-01 + SoC (n=48): 7.0 (4.8 to 11.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR) [From randomization to partial response or complete response up to 27 months]. Number, number participants with PR+CR. Arm 1-SoC (n=48): 15; Arm 2 -VCN-01 + SoC (n=48): 19.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) [From randomization to partial response or complete response up to 27 months]. Number, number of participants with PR+CR+SD. Arm 1-SoC (n=48): 34; Arm 2 -VCN-01 + SoC (n=48): 37.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Landmark 1-year Survival [From randomization to 1-year landmark]. Number, number of patients alive. Arm 1-SoC (n=41): 10; Arm 2 -VCN-01 + SoC (n=37): 13.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Patients With PFS at the 1-year Landmark [From randomization up to 12 months]. Count Of Participants, Participants. Arm 1-SoC (n=48): 10; Arm 2 -VCN-01 + SoC (n=48): 13.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DoR) [From randomization to disease progression assessed up to 27 months]. Median, months (95% Confidence Interval). Arm 1-SoC (n=48): 5.4 (1.9 to 6.8); Arm 2 -VCN-01 + SoC (n=48): 11.2 (7.4 to NA) [Not Calculable (Insufficient data) (according to the Clinical Study Report)].