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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: Recruiting Phase 2 study of Advanced Soft Tissue Sarcoma and Metastatic Alveolar Soft Part Sarcoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Initial response documented within first 12 cycles of treatment and confirmed 4-8 weeks after documentation of initial response by Response Evaluation Criteria in Solid Tumors version 1.1.
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 |
What NCT05333458 shows while recruiting
NCT05333458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 87-participant average among 6 other Advanced Soft Tissue Sarcoma trials with a reported enrollment target (69% lower).
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 lists 13 locations in 8 states (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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