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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

Must not have

Uncontrolled intercurrent illness

Active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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

Exclusion Criteria

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

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I do not have any unmanaged ongoing illnesses.

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I have active tuberculosis.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I have been treated with drugs targeting PD-1 or PD-L1.

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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.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have not received a live vaccine in the last 4 weeks and won't need one during the study.

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I have not had signs of infection in the last 2 weeks.

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I have not taken antibiotics in the last 2 weeks.

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I have a significant liver condition.

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I haven't taken any immune-boosting drugs in the last 6 weeks.

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I am HIV-positive, on treatment, and my viral load is undetectable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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 Rates (ORR)

Secondary study objectives

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 study objectives

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 • 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

Dysgeusia

Headache

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

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 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790