Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Atezolizumab Dosing for Cancer
Phase 1
Waitlist Available
Led By James L Gulley, M.D.
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
Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load
Age >=18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks and every 3 months on treatment
Awards & highlights
Study Summary
This trial tests different doses and timing of a drug used to treat cancer to see if it works with fewer side effects. Eligible adults with cancer can take part.
Who is the study for?
Adults aged 18+ with various advanced cancers (like lung, liver, melanoma) that have spread and are eligible for atezolizumab treatment can join. They must not be pregnant, breastfeeding (or willing to stop), and agree to use contraception. People with certain viral infections must have them under control. Those with a history of severe allergies or autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing if lower doses of atezolizumab, an immune system-boosting drug used in cancer treatment, are as effective as standard doses but cause fewer side effects. Participants will receive the FDA recommended dose initially then switch to the minimum dosage while researchers monitor drug levels in their blood over time.See study design
What are the potential side effects?
Atezolizumab may cause reactions where it's injected into the vein, fatigue, diarrhea or constipation, changes in blood tests that measure organ function and infection risk increase. Some people might experience skin rash or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had hepatitis C but now have no detectable virus.
Select...
I am 18 years old or older.
Select...
I have chronic hepatitis B but am on treatment and my virus levels are undetectable.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have HIV, am on treatment, and my viral load is undetectable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks and every 3 months on treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks and every 3 months on treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of reducing drug exposure while maintaining plasma drug concentration
Secondary outcome measures
Minimal frequency (median, range) of atezolizumab dosing to keep the trough concentration at or above 6 microgram/mL
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%
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: Arm 1Experimental Treatment1 Intervention
Atezolizumab treatment course
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
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
James L Gulley, M.D.Principal InvestigatorNational Cancer Institute (NCI)
19 Previous Clinical Trials
35,806 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks could participants in Arm 1 of the study face?
"Due to the limited safety and efficacy data available, our team determined Arm 1's safety rating was a conservative 1."
Answered by AI
Is there any possibility for me to be included in this research initiative?
"Qualified applicants for this trial must have alveolar soft part sarcoma and be between 18-120 years of age. This clinical study has a maximum capacity of 40 participants."
Answered by AI
Are there any vacancies open to join the clinical trial?
"As per information on clinicaltrials.gov, this particular medical trial is not seeking participants currently; the first posting was made October 9th 2023 and the latest update occurred in early October of 2023. However, there are 5374 other research trials actively recruiting patients right now."
Answered by AI
Does this research embrace individuals above the age of twenty-five?
"The parameters of this clinical trial require that participants must be aged between 18-120 years old. In contrast, there are 298 trails focussed on minors and 5268 trials for the elderly population."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger