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

Trial Details

NCT ID
NCT05333458
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Atezolizumab
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Selinexor
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Hartford, Connecticut, United States|41.76371,-72.68509
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • To be enrolled in the safety run-in, patients must have an advanced soft tissue sarcoma (not otherwise specified \[NOS\]). To be enrolled in the AS…
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter t…
  • Patients with unresectable, metastatic and measurable ASPS that is resistant/refractory to ICI treatment will be eligible for the ASPS cohort of th…
  • Age \>= 12 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with selinexor in patie…

For full eligibility, visit ClinicalTrials.gov.

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