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Monoclonal Antibodies
Atezolizumab + Cisplatin + Gemcitabine for Bladder Cancer
Phase 1 & 2
Waitlist Available
Led By Samuel Funt, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression.
Awards & highlights
Summary
This trial is testing whether adding atezolizumab to gemcitabine and cisplatin chemotherapy is safe and whether it works better than gemcitabine and cisplatin alone for treating pancreatic cancer.
Who is the study for?
Adults with bladder cancer that's invasive but hasn't been treated with chemotherapy or immunotherapy can join. They need to have a certain level of organ function, no severe allergies to the drug components, and agree to biopsies. Pregnant women and those with recent serious infections or heart issues cannot participate.
What is being tested?
The trial is testing if adding Atezolizumab (an immune system booster) to standard chemo drugs Gemcitabine and Cisplatin before surgery helps more than chemo alone. It's in phase II, so they're looking at how safe it is and how well it works.
What are the potential side effects?
Atezolizumab might cause lung problems like pneumonitis, reactions related to infusions, fatigue, liver issues, skin reactions, or worsen pre-existing autoimmune diseases. Standard chemo side effects include nausea, low blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Test the safety of atezolizumab in combination with gemcitabine/cisplatin as assessed by dose limiting toxicity rate.
Secondary study objectives
Relapse-Free Survival
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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab, Gemcitabine, CisplatinExperimental Treatment3 Interventions
This is a two phase study with a single study arm for each phase.
For Phase 1: Following enrollment participants will be treated with combination therapy on a 21 day cycle x 6 cycles. Gemcitabine (1000 mg/m2 on Day 1 and Day 8), cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.
Phase 2: Following enrollment participants will be treated with a single dose of atezolizumab alone followed by combination therapy on a 21-day cycle x 4 cycles, followed by a single dose of atezolizumab alone. Gemcitabine 1000mg/m2, cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Gemcitabine
FDA approved
Cisplatin
FDA approved
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,502 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,310 Total Patients Enrolled
Samuel Funt, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy before.You have a low count of a certain type of white blood cells called neutrophils.You have a sufficient amount of a type of white blood cell called lymphocytes.Your hemoglobin level is at least 9.0 grams per deciliter.You are allergic to Chinese hamster ovary cell products or any part of the atezolizumab medication.I have had a stem cell or organ transplant in the past.I have not received BCG treatment in the last 4 weeks.My cancer is confirmed as urothelial carcinoma by a lab test.My cancer is either locally advanced or has spread to other parts of my body.I am a woman who can have children and my pregnancy test is negative.I have a history of lung scarring or inflammation.I do not have an active or untreated brain tumor or cancer spread to my brain.I haven't taken any immune-weakening medications in the last 2 weeks.Your bilirubin levels are within a certain range, unless you have Gilbert's disease, in which case they can be a bit higher.I agree to have two biopsies for research during my treatment.You need to provide a sample of your bladder cancer tissue for testing.I have severe heart disease that limits my daily activities.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I have moderate to severe numbness or pain in my hands or feet.I am not pregnant or breastfeeding and agree to use contraception during and 5 months after treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I am not taking any medications that would exclude me from the trial.I have not used any experimental drugs in the last 4 weeks.I haven't had any cancer treatment in the last 3 weeks.I have had chemotherapy or immunotherapy for bladder cancer that has spread.I am 18 years old or older.My cancer can be measured and has a part that can be safely biopsied.My doctor agrees I can undergo major bladder surgery.I have moderate to severe hearing loss.I do not have any serious ongoing health or mental health conditions.I have HIV/AIDS.I have active hepatitis B or C.I have a significant liver condition, such as hepatitis or cirrhosis.You have had serious allergic reactions to certain types of medications made from antibodies or proteins.I haven't had any cancer other than my current one in the last 5 years.I have been treated with specific immune therapy drugs before.I have had radiation therapy targeted at my bladder.My blood clotting tests are normal or I am on a stable dose of blood thinners.You are expected to live for at least 12 weeks.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I have a heart rhythm problem, but it's controlled or treated.I do not have active tuberculosis or a BCG infection.I have had lung inflammation from past radiation, but it's now scar tissue.You cannot be participating in another clinical trial that involves getting medical treatment, but trials that focus on improving quality of life or providing supportive care are okay.You have had a disease where your immune system attacks your own body.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.My side effects from cancer treatment are mild, except for hair loss.I am taking bisphosphonates for high calcium levels due to cancer.I have a bone marrow disorder that may affect my treatment.I have skin conditions like eczema or psoriasis, but only on my skin.I am fully active or can carry out light work.I haven't taken any immune-boosting drugs in the last 6 weeks.You need to have at least 100,000 platelets per cubic millimeter of blood.Your AST and ALT levels are not more than 3 times the upper limit of normal for the testing center.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal for the institution.My bladder cancer has been confirmed to invade muscle, or it's in the prostate but confirmed by imaging.My cancer is in a localized stage but has grown beyond the original site.Your kidney function is good with a filtration rate of at least 60 ml/min/1.73m2.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab, Gemcitabine, Cisplatin
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
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