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Checkpoint Inhibitor

Atezolizumab After Adoptive Cell Transfer for Cancer

Phase 1

Waitlist Available

Led By Marcus O Butler

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

Histologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effective

ACT infusion prior to study enrollment (cohorts include ACT with tumor infiltrating lymphocytes [TIL], human leukocyte antigen [HLA]-class I T cell receptor [TCR]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor [CAR]-engineered T cells)

Must not have

Patients with a prior history of immune related events to anti-CTLA-4 may be eligible after discussion with the sponsor; however, patients with a history of grade 3 and 4 pulmonary, CNS and renal events attributed to anti-CTLA-4 agents will be excluded, Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible, Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible

History or risk of autoimmune disease that threatens vital organ function, including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of atezolizumab on patients who have had cancer and have had adoptive cell transfer.

Who is the study for?

Adults with advanced cancers not responding to standard treatments, who've had adoptive cell transfer (ACT), can join. They need a life expectancy over 3 months, certain blood and organ function levels, no recent cancer therapies except ACT, and measurable disease. Pregnant women or those with severe allergies to antibodies, active infections, or autoimmune diseases that could worsen are excluded.

What is being tested?

The trial is testing Atezolizumab's safety in patients after ACT therapy. It involves imaging tests like MRI and CT scans before and after treatment to see how the cancer responds. The study also includes biopsies and lab analyses to understand the drug's effects on tumors.

What are the potential side effects?

Atezolizumab may cause immune-related side effects such as inflammation of organs, infusion reactions similar to allergic responses, fatigue, liver issues indicated by abnormal blood tests results, skin reactions at injection sites among others.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, and standard treatments don't work or are unavailable.

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I have received ACT infusion therapy before joining this study.

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My leukemia or lymphoma can be measured for treatment response.

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I am 18 years old or older.

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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 have a tumor that can be measured and is big enough according to the guidelines.

Exclusion Criteria

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

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I have an autoimmune disease that could affect my vital organs.

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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

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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 do not have active tuberculosis.

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I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.

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I have a significant liver disease, such as hepatitis or cirrhosis.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Anti-tumor activity

Biomarker analysis

Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment

+4 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

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 Treatment6 Interventions

Patients receive atezolizumab IV over 30- 60 minutes on day 1. Cycles repeat every 21 days for a total of 17 doses over up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and biopsy on study. Patients also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180