Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05333458
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.
Study:
NCT05333458
Study Brief:
Protocol Section:
NCT05333458