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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05333458
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Alveolar Soft Part Sarcoma
  • Advanced Soft Tissue Sarcoma
  • Metastatic Alveolar Soft Part Sarcoma
  • Refractory Alveolar Soft Part Sarcoma
  • Unresectable Alveolar Soft Part Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Selinexor — DRUG
    Given PO

Study Details

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 Dates

Start date
Aug 29, 2022
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, selinexor)
    Patients receive atezolizumab IV over 30-60 minutes on day 8 of cycle 1, and then on day 1 of subsequent cycles. Patients also receive selinexor PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening and CT and collection of blood samples throughout the study. Adult patients also undergo biopsies throughout the study.

Primary Outcome Measure

Objective response rate [ Time Frame: Within first 12 cycles of treatment confirmed 4-8 weeks later (Each cycle = 28 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
Keck Medicine of USC KoreatownLos AngelesCalifornia90020
Site Public Contact
213-388-0908
Mark Agulnik (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Yale UniversityNew HavenConnecticut06520
Site Public Contact
[email protected]
203-785-5702
Philippos Apolinario Costa (PRINCIPAL_INVESTIGATOR)
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611
Site Public Contact
[email protected]
203-785-5702
Philippos Apolinario Costa (PRINCIPAL_INVESTIGATOR)
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Site Public Contact
202-444-2223
Benjamin A. Weinberg (PRINCIPAL_INVESTIGATOR)
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
David A. Liebner (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Minh Phan (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Melissa A. Burgess (PRINCIPAL_INVESTIGATOR)
UT MD Anderson Cancer CenterHoustonTexas77030
Site Public Contact
[email protected]
866-632-6789
Anthony P. Conley (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Keck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CASmilow Cancer Hospital Care Center at Saint Francis· Hartford, CTYale University· New Haven, CTSmilow Cancer Hospital Care Center-Trumbull· Trumbull, CT

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