Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DPX-Survivac · 1 trial · 3 indications
Objective Response Rate is the combined Complete Response (CR) and Partial Response (PR) rates using Cheson Criteria (2007) for evaluation. Site Qualified Investigators use radiological reports to calculate the decrease in tumour size from baseline at protocol specified time points.
| Arm | Type | Description |
|---|---|---|
| Single Arm-Investigational | EXPERIMENTAL | DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally. |
| Name | Type | Description |
|---|---|---|
| DPX-Survivac | BIOLOGICAL | DPX-Survivac Priming dose of 0.5ml on Study days 7 and 28. DPX-Survivac Booster dose of 0.1ml on Study days 84, 140, 196, 252, 308, and 364. |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab 200mg administered intravenously every 3 weeks, commencing on study day 7 to a total of 18 infusions |
| Cyclophosphamide 50mg | DRUG | Cyclophosphamide 50mg twice daily by mouth, administered 7 days on / 7 days off, stating at study day 0, until study day 384 |
Inclusion Criteria In order to be eligible for participation in this trial, the subject must: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Male or female 18+ years of age on day of signing informed consent and of any racial or ethnic group 3. Has: A. hist...