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Monoclonal Antibodies

Atezolizumab +/- Bevacizumab for Alveolar Soft Part Sarcoma

Phase 2
Recruiting
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

Study 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.Check my eligibility
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.See study design
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.
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Duration of response
Immune biomarkers in paired biopsies
Immune-related response
+2 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Computed Tomography
2017
Completed Phase 2
~2790
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,332 Total Patients Enrolled
Alice P ChenPrincipal InvestigatorNational Cancer Institute LAO
3 Previous Clinical Trials
167 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03141684 — Phase 2
Alveolar Soft Part Sarcoma Research Study Groups: Arm I (atezolizumab), Arm II (atezolizumab, bevacizumab)
Alveolar Soft Part Sarcoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03141684 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03141684 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being recruited for this research project at this time?

"The trial, as stated on the website clinicaltrials.gov, is recruiting patients right now. The original posting was on March 3rd 2017 with the latest edit being November 9th 2022."

Answered by AI

What are some of the conditions that Atezolizumab has been shown to help?

"Atezolizumab is an immunotherapy drug that can be used to treat non-small cell lung carcinoma, postoperative, and recurrent non-squamous non-small cell lung cancer."

Answered by AI

How many different medical clinics are participating in this study?

"37 hospitals and clinics are running this clinical trial, such as Keck Medicine of USC Buena Park in Buena Park, Keck Medicine of USC Koreatown in Phoenix, Mayo Clinic Hospital in Arizona in North Haven."

Answered by AI

How many patients are being treated with this new medication?

"In order to conduct this trial, 62 patients who meet the pre-determined inclusion criteria are required. The research can be conducted at multiple sites, such as Keck Medicine of USC Buena Park in Buena Park, Arizona and Keck Medicine of USC Koreatown in Phoenix, Connecticut."

Answered by AI

Can you elaborate on how Atezolizumab has been studied in the past?

"Atezolizumab was first studied in 2004 at Memoral Sloan Kettering Basking Ridge. 1116 trials have completed since then, with 645 more currently underway. Buena Park, Arizona is one of the many locations where these active studies are being conducted."

Answered by AI

What are the short- and long-term risks of Atezolizumab?

"Atezolizumab's safety is rated a 2. This comes from it being in Phase 2 of testing, where there are preliminary signs of safety but no data supporting efficacy."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~12 spots leftby Oct 2025