RecruitingPhase 2NCT05333458

Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial

A Phase 2 Study of Atezolizumab With Selinexor in Alveolar Soft Part Sarcoma (AXIOM)


Sponsor

National Cancer Institute (NCI)

Enrollment

27 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study (AXIOM Trial) is testing a combination of two drugs — atezolizumab (an immunotherapy) and selinexor (a targeted therapy) — in people aged 12 and older with alveolar soft part sarcoma (ASPS), a rare soft tissue cancer. **You may be eligible if...** - You are 12 or older with confirmed alveolar soft part sarcoma that cannot be cured by surgery - Your ASPS has measurable tumor lesions on imaging - Your ASPS progressed or didn't respond to prior immunotherapy - Your heart, liver, and kidney functions are adequate - You are in reasonably good health (ECOG status 0–2) **You may NOT be eligible if...** - You have received recent chemotherapy or radiation (within the last 4 weeks) - You have active symptomatic brain metastases - You have a significant autoimmune disease - You have active tuberculosis or a serious ongoing infection - You are pregnant or breastfeeding - You have had an organ or bone marrow transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGSelinexor

Given PO


Locations(13)

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05333458


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