drugset / Trial / NCT02824965
Pembrolizumab + CVA21 in Advanced NSCLC
Phase 1
Unknown
11 enrolled
Olivia Newton-John Cancer Research Institute
Merck Sharp & Dohme LLC · collabViralytics · collab
NaSingle-groupOpen-labelTreatment
Summary
This will be a Phase Ib open-label trial of CAVATAK™ (CVA21) in combination with Pembrolizumab for the treatment of patients with advanced NSCLC. The dose of Pembrolizumab will be fixed at 200mg. Three cohorts (dose levels) of intravenously-delivered CVA21 will be explored, using a standard 3+3 patient dose escalation design. The starting dose of CVA21 will be one log below the 1 x 10\^9 TCID50 dose found to be safe when CVA21 was given alone in an ongoing Phase I study (NCT02043665).
Timeline
- Start
- 2017-08-09
- Primary completion
- 2021-07-01
- Completion
- 2021-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gebasaxturev | Other / unclassified | 1e+09 unknown | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |