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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Anti-tumor activity
Biomarker analysis
Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment
+4 moreSide 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%
Respiratory tract infection
1%
Musculoskeletal chest pain
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 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
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Marcus O ButlerPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.My leukemia or lymphoma can be measured for treatment response.My side effects from previous cancer treatments are mild, except for possible hair loss, skin changes, or hormone issues.I agree to use birth control during and 5 months after the study due to risks to a fetus.I haven't taken any immune-weakening medications in the last 2 weeks.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for fibrosis from radiation.I have not received any live vaccines in the last 4 weeks and won't need any during the study.I have had treatments before, including immunotherapies.I am 18 years old or older.I am not pregnant or breastfeeding.My cancer is advanced, cannot be surgically removed, and standard treatments don't work or are unavailable.I don't have active brain cancer or symptoms from brain metastases that need steroids.I had anti-CTLA-4 antibody treatment over 6 weeks ago without severe side effects.I have an autoimmune disease that could affect my vital organs.My skin condition is under control, covers less than 10% of my body, and hasn't worsened in the past year.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I have completed ACT therapy and still have active cancer, confirmed by tests or biopsy.I have treated brain metastases with no recent progression or treatments.I am HIV positive with stable treatment, no opportunistic infection prevention needed, a CD4 count above 250, and undetectable viral load.I have received ACT infusion therapy before joining this study.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I haven't had any cancer treatment, including ACT, for the last 28 days.I do not have active tuberculosis.My blood clotting tests are within normal limits, or I am on a stable dose of blood thinners.I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.My condition can be monitored with before and after tissue samples.I have a significant liver disease, such as hepatitis or cirrhosis.I have not had signs of infection in the last 2 weeks.I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.I can take care of myself but might not be able to do heavy physical work.I have a tumor that can be measured and is big enough according to the guidelines.I haven't received anti-PD-1 or anti-PD-L1 therapy after ACT and before starting atezolizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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