drugset / Trial / NCT05141721
A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus a fluoropyrimidine/bevacizumab alone as assessed by molecular response which is based on changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regimen as assessed by progression-free survival.
Timeline
- Start
- 2022-02-12
- Primary completion
- 2027-03
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1680 mg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | LUTADENOVEC AUTOGENE | Vaccine | 1e+12 vg | Intramuscular |
| Subject | SAPECMERAN AUTOGENE | Messenger RNA (mRNA) | 30 ug | Intramuscular |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | Intravenous |