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Checkpoint Inhibitor
Atezolizumab for 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
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault for adult patients (>= 18 years of age) or age and gender specific serum creatinine for pediatric patients (< 18 years of age)
Patients must have documented EWSR1/ATF1 or EWSR1/CREB1 translocation or histologically confirmed clear cell sarcoma, documented grade 2 or 3 conventional chondrosarcoma, or documented dedifferentiated chondrosarcoma. The disease must not be curable by surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial studies atezolizumab in treating patients with chondrosarcoma or clear cell sarcoma.
Who is the study for?
This trial is for children and teens aged 2-17 with clear cell sarcoma or advanced chondrosarcoma that's either new, can't be surgically removed, or has spread. They should have a life expectancy over 3 months, certain blood counts within range, measurable disease, and no major health issues that could affect the trial. They must not have had recent vaccines or antibiotics and cannot be pregnant.Check my eligibility
What is being tested?
The study tests Atezolizumab's effectiveness against specific sarcomas in young patients. It involves collecting biospecimens and using CT scans to monitor the cancer's response to this immunotherapy drug designed to boost the body’s immune system in fighting cancer cells.See study design
What are the potential side effects?
Atezolizumab may cause allergic reactions related to infusion, lung inflammation (like pneumonitis), liver problems, infections due to weakened immunity, potential hormonal gland issues leading to hormone imbalances, fatigue, nausea and possibly other immune-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is adequate.
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My cancer is not removable by surgery and has specific genetic markers or is a certain type.
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I have a tumor that can be measured with imaging or physical exam.
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My heart function is classified as good or better.
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I can take care of myself but might not be able to do heavy physical work.
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I am at least 2 years old if at the NCI Clinical Center, or 12 years old at other sites.
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I am at least 2 years old if at NCI, or 12 years old at other sites.
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I have a tumor that can be measured and is at least as big as specified.
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I have a specific type of advanced sarcoma that is growing and cannot be surgically removed.
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My cancer has a specific genetic change or is a certain type of sarcoma.
Select...
I am mostly self-sufficient and can carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rates (ORR)
Secondary outcome measures
Duration of Response (DOR) or Change in Clinical Symptoms
Number of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor
Progression-free Survival (PFS) Time
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Musculoskeletal chest pain
1%
Respiratory tract infection
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over 30-60 minutes on ay 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and undergo biopsy and collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,337 Total Patients Enrolled
18 Trials studying Chondrosarcoma
1,565 Patients Enrolled for Chondrosarcoma
Alice P ChenPrincipal InvestigatorNational Cancer Institute LAO
4 Previous Clinical Trials
238 Total Patients Enrolled
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
7 Previous Clinical Trials
563 Total Patients Enrolled
1 Trials studying Chondrosarcoma
66 Patients Enrolled for Chondrosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine clearance, is adequate.You cannot have participated in any other experimental treatment within the last 4 weeks (or within five half lives of the investigational product, whichever is shorter) before starting this study.I have a specific type of cancer that is spreading and causing more symptoms.Your hemoglobin (a protein in your blood) levels are at least 8 grams per deciliter (a unit of measurement for blood).I do not have any unmanaged ongoing illnesses.I am willing to give samples for research and I am 18 or older.My brain cancer has not worsened for at least 1 month after treatment.I have active tuberculosis.I haven't had major surgery in the last 28 days and don't expect to need one during the study.My cancer is not removable by surgery and has specific genetic markers or is a certain type.I have a tumor that can be measured with imaging or physical exam.My heart function is classified as good or better.Your bilirubin levels are normal, but if you have a condition called Gilbert disease, your bilirubin levels can be up to three times the normal limit.I can take care of myself but might not be able to do heavy physical work.I have brain metastases but don't need immediate brain-specific treatment.I had cancer before, but it won't affect this treatment's test.I have been treated with drugs targeting PD-1 or PD-L1.I finished my last cancer treatment at least 4 weeks ago or 5 half-lives of the treatment, whichever is shorter, and have recovered from its side effects.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I have not received a live vaccine in the last 4 weeks and won't need one during the study.I have not had signs of infection in the last 2 weeks.You have a history or risk of an autoimmune disease.I am at least 2 years old if at the NCI Clinical Center, or 12 years old at other sites.You have enough platelets in your blood, with a count of at least 100,000/mcL.I am at least 2 years old if at NCI, or 12 years old at other sites.I haven't taken any immune-weakening drugs in the last 2 weeks.You are expected to live for at least 3 more months.I have a tumor that can be measured and is at least as big as specified.I have not taken antibiotics in the last 2 weeks.I have a significant liver condition.I have a specific type of advanced sarcoma that is growing and cannot be surgically removed.I haven't taken any immune-boosting drugs in the last 6 weeks.I am HIV-positive, on treatment, and my viral load is undetectable.I have not had severe infections in the last 4 weeks.My cancer has a specific genetic change or is a certain type of sarcoma.I am mostly self-sufficient and can carry out daily activities.You have a sufficient amount of a type of white blood cell called neutrophils, with a count of at least 1,000 per microliter of blood.You are currently pregnant or breastfeeding.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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