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Autologous Dendritic Cell-Adenovirus CCL21 Vaccine · 1 trial · 4 indications
Demographic characteristics of patients including age, gender ethnicity, performance status, prior therapies and other baseline characteristics as collected on the case report form will be summarized by Ad-CCL21-DC dose cohort using descriptive statistics. For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median, minimum, and maximum) will be provided. For categorical variables, patient counts and percentages will be provided. Categories for missing data will be presented if necessary. The ORR will be summarized using descriptive statistics by dose level. The ORR will be analyzed using one-sample exact Binomial test for the patients treated at MTD or MAD in both the dose escalation phase and dose expansion phase. The 95% exact confidence interval (CI) will be provided.
| Arm | Type | Description |
|---|---|---|
| Treatment (Ad-CCL21-DC vaccine, pembrolizumab) | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes followed by autologous dendritic cell-adenovirus CCL21 vaccine by CT-guided or bronchoscopic IT injection on days 0, 21, and 42. Patients then receive pembrolizumab every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Autologous Dendritic Cell-Adenovirus CCL21 Vaccine | BIOLOGICAL | Given via CT-guided or bronchoscopic IT injection |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Participants with histologically confirmed diagnosis of NSCLC will be enrolled in this study. * Stage IV pathologically proven NSCLC. * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * Must have received pr...
The Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is an investigational cancer vaccine being studied for the treatment of lung non-small cell carcinoma, specifically in patients with stage IV non-small cell lung cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
The Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of this investigational vaccine in patients with stage IV non-small cell lung cancer.
The Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is in Phase 1 clinical development. It is an investigational agent being studied in a single active clinical trial for stage IV non-small cell lung cancer. The vaccine is not yet approved and remains in early-stage clinical testing.
The Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is being evaluated in clinical trial NCT03546361, titled 'CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer.' This Phase 1 trial is active but not recruiting, with an enrollment of 24 participants in the United States.
The Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is a cancer vaccine that uses a patient's own dendritic cells modified with an adenovirus to express the CCL21 gene. This approach is designed to stimulate an immune response against cancer cells. It is being studied in combination with pembrolizumab in non-small cell lung cancer.