What side effects are associated with this type of intervention?

Atezolizumab, an immunotherapy monoclonal antibody, commonly causes side effects such as fatigue, decreased appetite, nausea, and immune-related adverse events like pneumonitis, colitis, and hepatitis. Selinexor, a selective inhibitor of nuclear export, often leads to side effects including nausea, vomiting, fatigue, decreased appetite, and low blood counts (thrombocytopenia, anemia, and neutropenia). Both treatments can have significant impacts on the immune system and require careful monitoring.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Alveolar Soft Part Sarcoma (ASPS) using Atezolizumab or Selinexor in the provided context. However, the trial mentioned is investigating the efficacy of Atezolizumab, an immunotherapy with monoclonal antibodies, and Selinexor, a selective inhibitor of nuclear export, for treating ASPS. These drugs are being tested for their potential to shrink tumors and stabilize cancer in patients with ASPS.

What other types of research exist?

Promising novel alternatives for Alveolar Soft Part Sarcoma patients include kinase inhibitors like sunitinib and regorafenib, which have shown efficacy in treating various sarcomas. Additionally, mTOR inhibitors such as everolimus and temsirolimus have been used successfully in certain sarcoma subtypes. These alternatives offer different mechanisms of action compared to Atezolizumab and Selinexor, potentially providing effective treatment options for ASPS patients.

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Monoclonal Antibodies

Atezolizumab +/− Selinexor for Sarcoma

Phase 2

Recruiting

Led By Geraldine O'Sullivan Coyne

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault

Patients must have an advanced soft tissue sarcoma (not otherwise specified [NOS]) to be enrolled in the safety run-in

Must not have

Patients with mild or moderate signs or symptoms of infection within 2 weeks prior to cycle 1, day 1

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if atezolizumab alone or with selinexor can shrink tumors in patients with a rare type of cancer called alveolar soft part sarcoma. Atezolizumab boosts the immune system to fight cancer, and selinexor stops cancer cells from growing. The goal is to see if these treatments work better than the usual care.

Who is the study for?

Adults (18+) with alveolar soft part sarcoma, a rare cancer, who can't be cured by surgery. They should have measurable tumor growth and acceptable organ function. HIV-positive patients must have an undetectable viral load on therapy. Participants need to agree to use contraception if applicable and provide biopsy samples for research.

What is being tested?

The trial is testing the effectiveness of Atezolizumab alone or combined with Selinexor against standard treatments for shrinking tumors in alveolar soft part sarcoma. It explores how these drugs might help the immune system fight cancer or block proteins that aid in cancer cell growth.

What are the potential side effects?

Atezolizumab may cause immune-related inflammation, fatigue, infusion reactions, while Selinexor could lead to nausea, vomiting, loss of appetite, weight loss, tiredness and changes in blood counts which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I have an advanced soft tissue sarcoma.

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My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.

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My ASPS is spreading and cannot be removed via surgery.

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I am mostly self-sufficient and can carry out daily activities.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had mild or moderate infection symptoms within the last 2 weeks.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have had leptomeningeal disease.

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I have not had major surgery in the last 28 days.

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I have a history of cancer.

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I have pain from my cancer that isn't relieved by treatment.

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I haven't taken any cancer treatments within the last 4 weeks or five half-lives, whichever is shorter.

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I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.

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I have a significant liver condition.

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I have a serious heart condition.

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I am currently on medication for hepatitis B.

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I have had a condition where my lymphocytes grow abnormally.

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I have active tuberculosis.

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I have not received a live vaccine in the last 4 weeks.

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I haven't taken any experimental drugs within the last 28 days.

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I have high calcium levels in my blood that are causing symptoms.

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I do not have conditions affecting my body's ability to absorb nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Secondary study objectives

Progressive disease (PD)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (atezolizumab)Experimental Treatment5 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Patients also undergo biopsy at baseline and cycle 3 day 1, CT and MRI at baseline, end of cycle 2, and every 2 cycles thereafter, and collection of blood samples throughout the study.

Group II: Arm I (atezolizumab, selienexor)Experimental Treatment6 Interventions

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 QW 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 biopsy at baseline, cycle 1 day 8 and cycle 3 day 1, CT and MRI at baseline, end of cycle 2, and every 2 cycles thereafter, and collection of blood samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Atezolizumab

2016

Completed Phase 3

~5860

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Selinexor

2020

Completed Phase 3

~1730

0 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atezolizumab, an immunotherapy with monoclonal antibodies, targets the PD-L1 protein to enhance the immune system's ability to recognize and attack cancer cells, while Selinexor, a selective inhibitor of nuclear export, blocks the CRM1 protein to prevent the export of tumor suppressor proteins from the nucleus, leading to cancer cell death. These targeted mechanisms are significant for Alveolar Soft Part Sarcoma patients as they provide focused strategies to inhibit tumor growth and boost the immune response against cancer cells.

Repolarization of tumor infiltrating macrophages and increased survival in mouse primary CNS lymphomas after XPO1 and BTK inhibition.Natural product pectolinarigenin inhibits osteosarcoma growth and metastasis via SHP-1-mediated STAT3 signaling inhibition.XPO1 inhibitor combination therapy with bortezomib or carfilzomib induces nuclear localization of IκBα and overcomes acquired proteasome inhibitor resistance in human multiple myeloma.