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NCT05333458 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Advanced Soft Tissue Sarcoma and Metastatic Alveolar Soft Part Sarcoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
27
Enrollment target
13
Study locations

NCT05333458 is a Phase 2 study of Advanced Soft Tissue Sarcoma and Metastatic Alveolar Soft Part Sarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 87-participant average among 6 other Advanced Soft Tissue Sarcoma trials with a reported enrollment target (69% lower). The trial reports 13 study locations across 8 states.

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The verdict

NCT05333458, a Phase 2 study of Advanced Soft Tissue Sarcoma and Metastatic Alveolar Soft Part Sarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
27 participants
Enrollment target
13
Study locations

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

Advanced Soft Tissue Sarcoma Metastatic Alveolar Soft Part Sarcoma Unresectable Alveolar Soft Part Sarcoma Advanced Alveolar Soft Part Sarcoma Refractory Alveolar Soft Part Sarcoma

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

FieldValue
Enrollment Target 27 participants
Start Date 2022-08-29
Est. Completion 2027-05-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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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, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 87-participant average among 6 other Advanced Soft Tissue Sarcoma trials with a reported enrollment target (69% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT05333458 reports 13 study locations spanning 8 distinct geographic areas - top geographies include California, Connecticut, Maryland.

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.

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).

Who is sponsoring clinical trial NCT05333458?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.