NCT04258956

A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Axitinib	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.

Timeline

• Start date: 2019-04-30
• Primary completion: 2021-04-30
• Completion: 2023-04-30
• First posted: 2020-02-06
• Last updated: 2025-09-11

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study