drugset / Trial / NCT06445972
Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.
Timeline
- Start
- 2024-08-07
- Primary completion
- 2028-05-09
- Completion
- 2030-08-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Patritumab deruxtecan | Monoclonal antibody | — | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 3 mg/kg | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 4 mg/kg | Intravenous |