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Report for Clinical Trial NCT04258956
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
To assess anti-tumor activity of avelumab in combination with axitinib in patients with
unresectable/metastatic GIST after progression on second or third line treatment (after
failure on at least of imatinib and sunitinib) in terms of progression-free survival (PFS)
Description: Avelumab 10 mg/kg will be administered every two weeks. Avelumab is administered as a 1-hour iv infusion, diluted with 0.9% saline solution; Axitinib 5 mg should be taken orally twice daily approximately 12 hours apart with or without food. They should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
The duration of treatment cycle is 28 days.
Primary Outcomes Measure: Participants Achieving 3-Month Progression-Free Survival (PFSR) Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria Time: 12 weeks
Single Group Assignment
There is one SNP
- Patients with PDGFRA D842V mutations are not eligible for this study. --- D842V ---