drugset / Trial / NCT05456165
Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus \[ChAd\] and self-amplifying messenger RNA \[samRNA\] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.
Timeline
- Start
- 2022-05-19
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1680 mg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | LUTADENOVEC AUTOGENE | Vaccine | — | Intramuscular |
| Subject | SAPECMERAN AUTOGENE | Messenger RNA (mRNA) | — | Intramuscular |
| Background | Oxaliplatin | Small molecule | — | — |