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Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
NCT05333458 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
Study Locations (13)
California
- Keck Medicine of USC Koreatown — Los Angeles
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford
- Yale University — New Haven
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
Maryland
- National Cancer Institute Developmental Therapeutics Clinic — Bethesda
- National Institutes of Health Clinical Center — Bethesda
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh
Texas
- M D Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-08-29 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05333458
The ClinicalTrials.gov registry entry for NCT05333458 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Advanced Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05333458 reports 13 study locations spanning 8 distinct geographic areas — top geographies include California, Connecticut, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05333458 about?
NCT05333458 is a clinical study titled "Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial". 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 al...
What is the current status of trial NCT05333458?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2022-08-29. Estimated completion is 2027-05-01.
What conditions does trial NCT05333458 study?
This clinical trial studies the following conditions: Advanced Soft Tissue Sarcoma, Metastatic Alveolar Soft Part Sarcoma, Unresectable Alveolar Soft Part Sarcoma, Advanced Alveolar Soft Part Sarcoma, Refractory Alveolar Soft Part Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05333458?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05333458?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05333458 being conducted?
This trial has 13 study locations across California, Connecticut, District of Columbia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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