Recruiting PHASE2 Advanced Alveolar Soft Part Sarcoma

New treatment option for Advanced Alveolar Soft Part Sarcoma

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

ClinicalTrials.gov ID: NCT05333458

What this study is testing

What is Atezolizumab?

Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced alveolar soft part sarcoma.

Also referred to as MPDL 3280A, MPDL 328OA.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 and older

You may be able to join 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...
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to...
Patients with unresectable, metastatic and measurable ASPS that is resistant/refractory to ICI treatment will be eligible for the ASPS cohort of this...
Age \>= 12 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with selinexor in...
Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)

You likely can't join 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...
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...
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...

See the full eligibility criteria

Who can join

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...
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...
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...
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...
Eastern Cooperative Oncology Group (ECOG) performance status =\ = 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...
Serum creatinine =\ = 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...
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...
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

What rules you out

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...
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 with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2...
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...
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...
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
Patients with uncontrolled intercurrent illness, prior malignancy, any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an...
Patients who are pregnant or breastfeeding, or are expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of...
Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. For...
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). For these patients, an HCV RNA test must be done within 28 days...
History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid...
Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided all of the following...
Rash must cover less than 10% of body surface area (BSA)
Disease is well controlled at baseline and only requiring low potency topical steroids
No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency...
History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on...
Patients with significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study...
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
Patients with active tuberculosis (TB) are excluded
Patients with mild or moderate signs or symptoms of infection within 2 weeks prior to cycle 1, day 1 (including, but not limited to, receiving oral or intravenous [IV] antibiotics) are excluded. Patients with severe...
Major surgical procedure within 28 days prior to cycle 1, day 1
Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of...
Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time...
History of leptomeningeal disease
Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry, with no changes to their pain regimen in the 4 weeks prior to enrollment
Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation...
Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be...
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Patients with indwelling catheters (e.g., PleurX [registered trademark]) are allowed
Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
Current treatment with anti-viral therapy for HBV
Treatment with investigational therapy within five half-lives or 28 days prior to initiation of study treatment, whichever is shorter

The study team makes the final eligibility decision.

Where it's taking place

Los Angeles, California, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Trumbull, Connecticut, United States
Washington D.C., District of Columbia, United States
Bethesda, Maryland, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States; Washington D.C., District of Columbia, United States; Bethesda, Maryland, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.