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Tiragolumab + Atezolizumab for Bladder Cancer
Phase 1 & 2
Recruiting
Led By Padmanee Sharma, MD, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible for R0 resection with curative intent at the time of screening
Agreement for men to remain abstinent or use a condom
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing if a combination of two drugs can help control bladder cancer before surgery.
Who is the study for?
This trial is for adults with high-risk urothelial carcinoma who can't take cisplatin or refused it, and are fit enough for bladder surgery. They must have good lung function, no severe infections or recent major surgeries, not be on certain medications, and agree to use contraception if applicable. People with active TB, certain heart conditions, other cancers within 5 years, or autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study tests whether combining two drugs (Tiragolumab and Atezolizumab) before surgery can better control bladder cancer compared to current treatments. Participants will receive these drugs prior to their planned surgical procedure to remove the tumor.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment-induced exhaustion, potential infection risks due to immune system suppression by the drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a surgery aimed at completely removing my cancer.
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I agree to either not have sex or use a condom.
Select...
I agree not to donate sperm during the trial.
Select...
I am fully active or can carry out light work.
Select...
My lungs work well enough for surgery to remove my cancer.
Select...
My bladder cancer is confirmed to be invasive and high-risk.
Select...
I have tested positive for hepatitis B antibodies or meet specific criteria for a negative result.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate overall survival (OS).
To evaluate relapse-free survival (RFS)
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%
Peripheral sensory neuropathy
7%
Pain in extremity
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
2Treatment groups
Experimental Treatment
Group I: TiragolumabExperimental Treatment1 Intervention
Tiragolumab will be administered at a fixed dose of 600 mg intravenously Q3W on Day 1 of each 21-day cycle.
Group II: AtezolizumabExperimental Treatment1 Intervention
Atezolizumab will be administered at a fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21 day cycle),
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,351 Total Patients Enrolled
Padmanee Sharma, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for a surgery aimed at completely removing my cancer.I have had a previous transplant of stem cells or an organ.I have not received a live vaccine recently.I have not taken any antibiotics by mouth or IV in the last 2 weeks.I have a history of lung conditions.I agree to either not have sex or use a condom.I haven't taken any immune-boosting drugs recently.I have not taken immunosuppressive drugs recently.I agree not to donate sperm during the trial.I am over 18 years old.I have not had any cancer other than bladder cancer in the last 5 years.I have received treatment for bladder cancer before.I have had leptomeningeal disease.I have not had serious heart problems in the last 3 months.My doctor says I can't receive cisplatin treatment.I am fully active or can carry out light work.I have previously received specific immune therapies.I tested positive for a recent Epstein-Barr virus infection.I have an autoimmune disease or immune deficiency, with some exceptions.I do not have any health issues that prevent me from taking experimental medications.My lungs work well enough for surgery to remove my cancer.I have not had major surgery in the last 4 weeks.My bladder cancer is confirmed to be invasive and high-risk.I have active tuberculosis.My blood, organs, and bone marrow are functioning well.I am currently on medication for hepatitis B.I have tested positive for hepatitis B antibodies or meet specific criteria for a negative result.I have not had a severe infection in the last 4 weeks.My bladder tissue was removed recently at MD Anderson or another facility.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
- Group 2: Tiragolumab
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.
Is there still room to join this medical experiment?
"According to clinicaltrials.gov, this medical examination is not presently soliciting participants and has been inactive since the last update on May 26th 2022. However, there are still 170 ongoing studies that are actively recruiting patients for their trials."
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