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Monoclonal Antibodies

Atezolizumab +/- Bevacizumab for Alveolar Soft Part Sarcoma

Phase 2

Waitlist Available

Led By Alice P Chen

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

Patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery

Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well atezolizumab or atezolizumab plus bevacizumab works in treating patients with alveolar soft part sarcoma.

Who is the study for?

This trial is for people with advanced alveolar soft part sarcoma that can't be removed by surgery. Participants must have certain blood cell counts, organ function levels, and a life expectancy over 3 months. They should not have had recent severe infections or major surgeries, and cannot be pregnant or breastfeeding. Adults and children over 2 years old may join; however, only adults can receive the combination treatment.

What is being tested?

Researchers are testing if atezolizumab alone or combined with bevacizumab is effective in treating this type of sarcoma. Atezolizumab aims to boost the immune system's ability to fight cancer cells while bevacizumab targets tumor blood supply.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in organs, infusion-related reactions, increased risk of infection, bleeding complications from bevacizumab especially when used with NSAIDs or anticoagulants, high blood pressure, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

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

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My alveolar soft part sarcoma cannot be cured with surgery.

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My cancer diagnosis has been confirmed by the pathology department where I am enrolled.

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My liver is functioning within the required range.

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I have previously been treated with anti-CTLA-4 therapy.

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I am not pregnant, do not have HIV, and do not have any uncontrolled illnesses.

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My condition worsened despite being treated with atezolizumab.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidneys are functioning well enough to filter waste.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Duration of response

Immune biomarkers in paired biopsies

Immune-related response

+2 more

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, bevacizumab)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT imaging, and collection of blood and urine at baseline.

Group II: Arm I (atezolizumab)Experimental Treatment3 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT imaging, and collection of blood and urine at baseline. (CLOSED TO ACCRUAL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Computed Tomography

2017

Completed Phase 2

~2740