OncoMatch/Clinical Trials/NCT05333458
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
Is NCT05333458 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Selinexor for advanced alveolar soft part sarcoma.
Treatment: Atezolizumab · Selinexor — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor
resistant/refractory to ICI treatment ... evidence of disease progression after receiving prior ICI therapy
Cannot have received: chemotherapy
Exception: allowed if >4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C)
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: radiotherapy
Exception: palliative radiotherapy for bone metastases >2 weeks prior to cycle 1, day 1 is allowed
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: systemic immunostimulatory agents (interferon, interleukin 2)
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Cannot have received: systemic immunosuppressive medications (prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents)
Exception: acute, low dose, or one-time pulse dose systemic immunosuppressant medication allowed after PI confirmation; mineralocorticoids, corticosteroids for COPD/asthma, or low-dose corticosteroids for orthostatic hypotension/adrenocortical insufficiency allowed
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1 or anticipation of need for systemic immunosuppressive medication during study treatment
Cannot have received: investigational therapy
Treatment with investigational therapy within five half-lives or 28 days prior to initiation of study treatment, whichever is shorter
Cannot have received: other anti-cancer agent
Treatment with any other agent administered for the treatment of the patient's cancer, within five half-lives or 3 weeks prior to cycle 1, day 1, whichever is shorter
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min/1.73 m² by Cockcroft-Gault
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease); AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN for patients with liver metastases
Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease); AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN for patients with liver metastases; Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min/1.73 m² by Cockcroft-Gault; Serum albumin ≥ 2.5 g/dL; Baseline sodium (Na+) ≥ 130 mEq/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Keck Medicine of USC Koreatown · Los Angeles, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- Smilow Cancer Hospital Care Center at Saint Francis · Hartford, Connecticut
- Yale University · New Haven, Connecticut
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