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 - AXAGIST

Centrum Onkologii – Instytut im. Marii Sklodowskiej - Curie0 sites17 target enrollmentFebruary 27, 2019

ConditionsGIST - unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy MedDRA version: 20.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsInlyta Bavencio

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: GIST - unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy
Sponsor: Centrum Onkologii – Instytut im. Marii Sklodowskiej - Curie
Enrollment: 17
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Centrum Onkologii – Instytut im. Marii Sklodowskiej - Curie

Eligibility Criteria

Inclusion Criteria

•1\.Signed written informed consent.
•2\.Male or female subjects aged \= 18 years.
•3\.Histologically proven locally advanced or metastatic GIST. C\-Kit (CD117\) positive tumors detected by immunohistochemistry
•4\.Known mutational status KIT or PDGFRA.
•5\.Documented disease progression (as per RECIST 1\.1\) within 3 months before study entry
•6\.No more than 3 previous lines of treatment, which must include imatinib and sunitinib .
•7\.Performance status \= 2 at trial entry and an estimated life expectancy of at least 3 months.
•8\.Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1\.1\. Clinically and/or radiographically documented measurable disease within 21 days prior to registration
•CT\-scan, physical exam \=10 mm
•Chest X\-ray \=20 mm

Exclusion Criteria

•1\.Concurrent anticancer treatment within 14 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy \[with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin); major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy); use of hormonal agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment.
•2\.Patients with PDGFRA D842V mutations are not eligible for this study.
•3\.Previous treatment with anti\-PD\-1 or anti\-PD\-L1 antibodies, previous therapy with axitinib.
•4\.Persisting toxicity related to prior therapy Grade \> 1 CTCAE v 4\.0,
•5\.Major surgical procedure within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment; or minor surgical procedures, within 24 hours prior to the first study treatment;
•6\.Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•7\.Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid. The use of inhaled corticosteroids for chronic obstructive pulmonary disease is allowed.
•8\.History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra\-abdominal abscess within 6 months of enrollment;
•9\.History of idiopathic pulmonary fibrosis (including pneumonitis), drug\-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
•10\.Significant acute or chronic infections including, among others: positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);