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Monoclonal Antibodies
Atezolizumab + Chemotherapy for Bladder Cancer (IMvigor130 Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (</=) 2
Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
IMvigor130 Trial Summary
This trial is testing atezolizumab, a new type of immunotherapy, to see if it can help treat people with urothelial cancer that has not yet been treated.
Who is the study for?
This trial is for adults with untreated advanced urothelial carcinoma, who haven't had chemotherapy for this condition and are eligible to receive platinum-based chemotherapy. They must have measurable disease, agree to use effective contraception, and not be pregnant or breastfeeding. Prior local treatments are okay if completed at least 4 weeks before the study starts.Check my eligibility
What is being tested?
The study tests Atezolizumab alone and combined with platinum-based chemotherapy (Carboplatin or Cisplatin) plus Gemcitabine against just the chemotherapy in patients with advanced bladder cancer. It's a Phase III trial where participants are randomly assigned to different treatment groups.See study design
What are the potential side effects?
Atezolizumab can cause immune-related side effects like inflammation of organs, infusion reactions, fatigue, infections; Chemotherapy may lead to nausea, hair loss, blood cell count changes increasing infection risk.
IMvigor130 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is an advanced or spread urothelial carcinoma.
Select...
I have not had chemotherapy for my advanced urinary cancer that cannot be removed by surgery.
Select...
I agree to not have sex or use birth control and not donate sperm.
IMvigor130 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Secondary outcome measures
Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
IRF-PFS
+14 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
IMvigor130 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab+Gemcitabine+Carboplatin/CisplatinExperimental Treatment4 Interventions
Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Group II: Atezolizumab MonotherapyExperimental Treatment1 Intervention
Eligible participants will receive open-label atezolizumab as monotherapy.
Group III: Placebo+Gemcitabine+Carboplatin/CisplatinPlacebo Group4 Interventions
Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,087,855 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,355 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lining of my brain and spinal cord.I have previously been treated with specific immune therapy drugs.I haven't had severe infections or taken antibiotics in the last 4 weeks.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.You have had severe allergic reactions to certain medications made from combining different parts of antibodies or proteins.I had chemo for bladder cancer over a year ago and haven't had treatment since it came back.I have stable brain metastases and haven't had recent brain surgery or radiation.I completed bladder cancer treatment at least 4 weeks ago.I have not had chemotherapy for my advanced urinary cancer that cannot be removed by surgery.I haven't had any cancer treatment, including chemotherapy or hormonal therapy, in the last 3 weeks.I have brain metastases that are either active or not treated.I haven't taken any steroids or immune-weakening drugs in the last 2 weeks.I have pain or high calcium levels due to my cancer that isn't managed well.My heart's pumping ability is below 40%.I am allergic to certain medications made in Chinese hamster ovary cells.I have a history of lung scarring or inflammation not caused by infections.I have active tuberculosis.I have not received a live vaccine in the last 4 weeks.I haven't been part of any clinical study or taken experimental drugs in the last 28 days.I agree to use effective birth control or abstain from sex during and after treatment.I can take care of myself and am up and about more than half of my waking hours.I have active hepatitis B or C.My doctor thinks I can undergo platinum-based chemotherapy.My cancer is an advanced or spread urothelial carcinoma.I do not need frequent procedures to remove excess fluid from my body.I can provide enough tumor samples for PD-L1 testing.My blood counts and organ functions are within normal ranges.I agree to not have sex or use birth control and not donate sperm.You have less than 3 months to live.You have a history of a disease where your immune system attacks your own body.You have received a transplant of stem cells or an organ from another person in the past.I have not had any cancer other than bladder cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
- Group 2: Placebo+Gemcitabine+Carboplatin/Cisplatin
- Group 3: Atezolizumab Monotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Will Atezolizumab create any long-term safety concerns for patients?
"Atezolizumab has undergone multiple rounds of testing for safety and efficacy, so it has been rated a 3 in terms of safety."
Answered by AI
Are there any openings for participants in this research project?
"Unfortunately, this particular study is no longer recruiting patients. The listing was created on June 30th, 2016 but was last updated on October 13th, 20222. However, there are presently 2586 studies actively searching for patients with carcinoma and 1718 studies for Atezolizumab actively enrolling participants."
Answered by AI
What are some of the primary conditions that Atezolizumab has been shown to improve?
"Atezolizumab is often used to treat patients that have received adjuvant anthracycline-containing therapy in the past. However, this medication can also help those struggling with advanced endometrial cancer, melanoma, and metastatic ureter urothelial carcinoma."
Answered by AI
In how many different medical care facilities is this research project being conducted today?
"There are 27 sites running this clinical trial, including Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) in Saint Petersburg, Sarah Cannon Cancer Center in Germantown, and Parkview Research Center in Fort Wayne, as well as 24 other locations."
Answered by AI
Could you tell me if Atezolizumab has been used in other research projects?
"Atezolizumab was first studied over 20 years ago, in 1997. To date, there have been over 20,000 completed trials. There are 1,718 live studies being conducted currently, many of which are based in Saint Petersburg, Florida."
Answered by AI
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