Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 2:09 PM
Study NCT ID:
NCT05333458
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2022-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of Atezolizumab With Selinexor in Alveolar Soft Part Sarcoma (AXIOM)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests whether atezolizumab in combination with selinexor works to shrink tumors in patients with alveolar soft part sarcoma and whether the study drugs are better than the usual approach in treating this type of cancer. The usual approach is defined as care most people get for alveolar soft part sarcoma if they are not part of a clinical study, which includes treatment with radiation, kinase inhibitor drugs, immunotherapy drugs, or chemotherapy drugs. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may help keep cancer cells from growing and may kill them. Giving atezolizumab in combination with selinexor may help shrink tumors and stabilize the cancer in patients with alveolar soft part sarcoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine the overall response rate (by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1) for selinexor in combination with atezolizumab in patients with alveolar soft part sarcoma (ASPS) whose disease progressed and who have received prior immune checkpoint inhibitor (ICI) therapy.
SECONDARY OBJECTIVE:
I. Assess the number of activated CD8+ T cells infiltrating the tumor before and after atezolizumab + selinexor combination treatment, and correlate treatment-induced changes with clinical response.
EXPLORATORY OBJECTIVES:
I. Compare RECIST v 1.1 versus (vs) immune RECIST (iRECIST) in patients with ASPS on atezolizumab + selinexor.
II. Examine changes in PD-1/PD-L1 expression in the tumor microenvironment before and after atezolizumab + selinexor treatment, and correlate treatment-induced changes with clinical response.
III. Evaluate potential associations between atezolizumab + selinexor activity and expression of PD-L1 and apoptosis markers (γH2AX, activated caspase 3 and 8) in tumor biopsies.
IV. Evaluate potential associations between atezolizumab + selinexor activity and genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA).
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 8 of cycle 1, and then on day 1 of subsequent cycles. Patients also receive selinexor orally (PO) on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) during screening and computed tomography (CT) and collection of blood samples throughout the study. Adult patients also undergo biopsies throughout the study.
After completion of study treatment, participants are followed up for 30 days.
I. Determine the overall response rate (by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1) for selinexor in combination with atezolizumab in patients with alveolar soft part sarcoma (ASPS) whose disease progressed and who have received prior immune checkpoint inhibitor (ICI) therapy.
SECONDARY OBJECTIVE:
I. Assess the number of activated CD8+ T cells infiltrating the tumor before and after atezolizumab + selinexor combination treatment, and correlate treatment-induced changes with clinical response.
EXPLORATORY OBJECTIVES:
I. Compare RECIST v 1.1 versus (vs) immune RECIST (iRECIST) in patients with ASPS on atezolizumab + selinexor.
II. Examine changes in PD-1/PD-L1 expression in the tumor microenvironment before and after atezolizumab + selinexor treatment, and correlate treatment-induced changes with clinical response.
III. Evaluate potential associations between atezolizumab + selinexor activity and expression of PD-L1 and apoptosis markers (γH2AX, activated caspase 3 and 8) in tumor biopsies.
IV. Evaluate potential associations between atezolizumab + selinexor activity and genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA).
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 8 of cycle 1, and then on day 1 of subsequent cycles. Patients also receive selinexor orally (PO) on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) during screening and computed tomography (CT) and collection of blood samples throughout the study. Adult patients also undergo biopsies throughout the study.
After completion of study treatment, participants are followed up for 30 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: