Actively Recruiting
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
27
Participants Needed
13
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have advanced soft tissue sarcoma for the safety run-in or confirmed alveolar soft part sarcoma not curable by surgery for the ASPS cohort
- Must have measurable disease with at least one lesion at least 2 cm by chest x-ray or 1 cm by CT, MRI, or clinical exam
- Disease must be resistant or refractory to prior immune checkpoint inhibitor therapy with evidence of progression
- Age 12 years or older
- ECOG performance status of 0, 1, or 2 (Karnofsky score of 70% or higher)
- Absolute neutrophil count of at least 1,000/mcL
- Platelet count of at least 100,000/mcL
- Hemoglobin level of at least 9 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (or up to 3 times with Gilbert disease)
- AST/ALT less than or equal to 2.5 times upper limit of normal or up to 5 times for patients with liver metastases
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance 30 mL/min/1.73 m2 or higher
- Serum albumin of at least 2.5 g/dL
- Baseline sodium level of at least 130 mEq/L
- HIV-positive patients on effective anti-retroviral therapy with undetectable viral load are eligible
- Agree to use highly effective contraception during and after study participation
- Willing and able to provide informed consent
- Willing to provide biopsy samples unless enrolled in safety run-in
- Ability and willingness to swallow pills
- COVID-19 vaccines are allowed
You will not qualify if you...
- Malabsorption syndrome or any condition affecting intestinal absorption
- Chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C), except specified allowed therapies
- Current treatment with other cancer agents within five half-lives or 3 weeks prior to study
- History of other malignancies except those with low risk of metastasis or death
- Treatment with systemic immunostimulatory or immunosuppressive medications within specified timeframes, except certain low-dose or stable treatments
- Bisphosphonate therapy for symptomatic hypercalcemia (other uses allowed)
- Known primary CNS malignancy or symptomatic CNS metastases, with some exceptions for stable asymptomatic CNS disease
- History of severe allergic reactions to atezolizumab or selinexor
- Uncontrolled intercurrent illness or conditions increasing risk from treatment
- Pregnant or breastfeeding women, or those planning pregnancy during study and follow-up
- Prior allogeneic bone marrow or solid organ transplantation
- Significant liver disease, except past/resolved hepatitis B or controlled hepatitis C
- History or risk of autoimmune disease, with some controlled exceptions
- History of certain lung diseases or active pneumonitis
- Significant cardiovascular disease within 3 months prior to treatment
- Active tuberculosis
- Recent infections or severe infections within specified timeframes
- Major surgery within 28 days prior to study
- Recent live attenuated vaccine administration
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or symptomatic lesions needing treatment
- Uncontrolled fluid buildup requiring frequent drainage
- Other diseases or conditions contraindicating investigational drug use
- Current antiviral therapy for hepatitis B
- Recent investigational therapy within specified timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
7
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
9
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
10
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
11
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
12
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
13
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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