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

Recruiting now · Phase 2

Conditions studied: Advanced Alveolar Soft Part Sarcoma, Advanced Soft Tissue Sarcoma, Metastatic Alveolar Soft Part Sarcoma, Refractory Alveolar Soft Part Sarcoma, Unresectable Alveolar Soft Part Sarcoma

In brief

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.

Key facts

Study ID

NCT05333458

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2022-08-29

Expected to finish

2027-05-01

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ASPS cohort, patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam.
• Patients with unresectable, metastatic and measurable ASPS that is resistant/refractory to ICI treatment will be eligible for the ASPS cohort of this study if they show clinical and/or radiological evidence of disease progression after receiving prior ICI therapy (including history and increasing physical symptoms). On-study documentation will include a physician's rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)
• Age >= 12 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with selinexor in patients ˂ 18 years of age, children < 12 years of age are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 70%)
• Absolute neutrophil count >= 1,000/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 9 g/dL
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN or =< 5 x ULN for patients with liver metastases
• Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 30 mL/min/1.73 m\^2 by Cockcroft-Gault
• Serum albumin >= 2.5 g/dL
• Baseline sodium (Na+) >= 130 mEq/L
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 28 days are eligible for this trial
• Administration of selinexor or atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Female patients of child-bearing potential and male patients must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, for 90 days after the last dose of selinexor, and for 150 days after the last dose of atezolizumab, whichever is longer. Breastfeeding is not allowed while on selinexor or for 90 days after the last dose of selinexor. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to provide biopsy samples for research purposes, except patients enrolled on the safety run-in. Patients that cannot be safely biopsied may be considered for the study upon discussion with principal investigator
• Ability and willingness to swallow pills
• Vaccines intended to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease 2019 (COVID-19) are allowed

You may not qualify if…

• Malabsorption syndrome or other conditions that would interfere with intestinal absorption
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. However, the following therapies are allowed:
• Hormone-replacement therapy or oral contraceptives
• Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anti-cancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
• Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
• 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
• History of malignancy other than ASPS prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer
• 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
• 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, with the following exceptions:
• Patients who have received acute, low dose, systemic immunosuppressant medications or one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible after Principal Investigator confirmation has been obtained
• Patients who have received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenocortical insufficiency are eligible
• Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
• Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
• Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
• Evaluable or measurable disease outside the CNS
• No metastases to brain stem, midbrain, pons, medulla, or cerebellum
• No history of intracranial hemorrhage or spinal cord hemorrhage
• No ongoing requirement for dexamethasone for CNS; patients on a stable dose of anticonvulsants are permitted.
• No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1
• Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
• Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study
• No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1
• Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab or selinexor

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Keck Medicine of USC Koreatown — Los Angeles, California, United States (enrolling)
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
• Los Angeles General Medical Center — Los Angeles, California, United States (enrolling)
• National Cancer Institute Developmental Therapeutics Clinic — Bethesda, Maryland, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• UT MD Anderson Cancer Center — Houston, Texas, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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