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

NCT04258956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2021-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258956 on ClinicalTrials.gov