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Report for Clinical Trial NCT04258956

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II, Single Arm Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy - AXAGIST

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)

NCT04258956 Gastrointestinal Stromal Tumors
MeSH:Gastrointestin Gastrointestinal Stromal Tumors
HPO:Gastrointestinal stroma tumor

1 Interventions

Name: Axitinib

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.
Type: Drug


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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 D842V

- Patients with PDGFRA D842V mutations are not eligible for this study. --- D842V ---



HPO Nodes


HPO: