drugset / Trial / NCT03399071
Study Title: Peri-operative Immuno-Chemotherapy in Operable Oesophageal and Gastric Cancer
Phase 2
Unknown
44 enrolled
Royal Marsden NHS Foundation Trust
Merck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment
Summary
A single centre phase II trial of peri-operative chemo-immunotherapy in operable gastro-oesophageal adenocarcinoma (GOA). This trial is designed to evaluate the safety and efficacy of administering Avelumab, an anti-PD-L1 monoclonal antibody, with cytotoxic FLOT chemotherapy for patients with operable GOA treated according to a peri-operative protocol. This trial is in 2 stages: the first stage will establish the safe and tolerated maximum administered dose (MAD) of Avelumab in combination with FLOT and the second stage will assess the efficacy of this combination therapy in achieving pathological complete response (pCR) and peri-operative safety.
Timeline
- Start
- 2017-07-31
- Primary completion
- 2022-11-01
- Completion
- 2025-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 7 mg/kg | Intravenous |
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2600 mg/m2 | Intravenous |