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Alkylating agents
Chemotherapy + Durvalumab for Bladder Cancer
Phase 2
Recruiting
Led By Matthew Campbell
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
Patients must be ≥18 years of age.
Patients must provide tissue by agreeing to transurethethral biopsy of the bladder and the lymph node prior to initiating treatment. If patient is unable or unwilling to undergo biopsy at screening and tissue is available, patient may be eligibile per PI discretion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that includes the drug durvalumab, to see if it is more effective than the current standard of care chemotherapy.
Who is the study for?
This trial is for adults with bladder cancer that has spread to pelvic lymph nodes but not beyond. They must be in good physical condition, have a life expectancy of at least 12 weeks, weigh over 30 kg, and have proper heart and organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The study compares standard chemotherapy (cisplatin) with or without Durvalumab in patients with urothelial carcinoma of the bladder. Participants will be randomly assigned to receive either just chemotherapy or chemotherapy plus Durvalumab, which continues as maintenance for up to one year.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to Durvalumab affecting organs like the liver or lungs, infusion reactions from drug administration, fatigue, nausea from chemotherapy drugs like Cisplatin and Doxorubicin Hydrochloride, blood disorders such as low counts of white cells or platelets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I agree to provide tissue samples for biopsy before starting treatment.
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My doctor confirmed a lymph node in my pelvis can be biopsied.
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My bladder cancer is at a specific stage where it has spread to nearby lymph nodes but not to distant parts of my body.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not pregnant, cannot become pregnant, and will use birth control during the study.
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I weigh more than 30 kilograms.
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Your blood, kidney, liver, and blood clotting functions are within normal levels.
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 estimate the difference in the pathologic complete response rate.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Intervention with dose-dense MVAC plus DurvalumabExperimental Treatment6 Interventions
Durvalumab will be administered one week prior to the initial cycle of dose-dense MVAC and then with each additional cycle of dose-dense MVAC on Arm B
Group II: Arm A: Standard of Care with dose-dense MVACExperimental Treatment6 Interventions
The patient will receive treatment every 14 days for up to 6 cycles in the neoadjuvant setting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940
Vinblastine
1998
Completed Phase 3
~5260
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,742 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,726 Total Patients Enrolled
Matthew CampbellPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke, heart attack, or severe chest pain in the last 6 months.I am 18 years old or older.Your heart is pumping blood normally.I agree to provide tissue samples for biopsy before starting treatment.I have had an organ transplant from another person.I have another cancer that is getting worse or needs treatment.I have severe heart failure.I experience significant numbness or pain due to nerve damage.My doctor confirmed a lymph node in my pelvis can be biopsied.You have a history of a weakened immune system from birth.I have moderate to severe hearing loss.I have been treated with immunotherapy for another cancer.I haven't taken strong immune-weakening medicines in the last 28 days, except for common nasal or asthma sprays.I have previously been treated with drugs targeting PD-1 or PD-L1.I have not received a live vaccine in the last 30 days.I do not have any serious ongoing illnesses that could affect my participation in the study.I do not have an active tuberculosis infection.I haven't had bladder treatments in the last 4 weeks or have recovered from their side effects.I am not pregnant or breastfeeding and willing to use two forms of birth control for 90 days after the last dose.I do not have active Hepatitis B, Hepatitis C, or HIV.I have had an autoimmune disease in the last 2 years.My bladder cancer is at a specific stage where it has spread to nearby lymph nodes but not to distant parts of my body.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, cannot become pregnant, and will use birth control during the study.I do not have an active infection needing IV antibiotics or a severe illness requiring hospitalization.I weigh more than 30 kilograms.Your blood, kidney, liver, and blood clotting functions are within normal levels.My cancer has spread to lymph nodes outside my pelvis or to organs.I am allergic to methotrexate, vinblastine, doxorubicin, cisplatin, durvalumab, or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Standard of Care with dose-dense MVAC
- Group 2: Arm B: Intervention with dose-dense MVAC plus Durvalumab
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.
Are participants being recruited for this research project at this time?
"The clinical trial is presently searching for patients. The study was initially posted on 10/13/2021 and was last edited on 6/2/2022."
Answered by AI
What is the unique selling point of this clinical trial?
"Since 1997, Vinblastine has been the subject of medical research with Alfacell sponsoring the first study. The Phase 3 drug approval followed a successful trial of 300 patients in 1997. Presently, there are 1505 active trials for Vinblastine being conducted in 81 countries and across 3690 cities."
Answered by AI
Is it dangerous to take Vinblastine?
"Vinblastine is a Phase 2 drug, meaning while there is some evidence indicating it is safe, there is currently no data to support its efficacy."
Answered by AI
Why is Vinblastine given to patients?
"While often used to treat testicular cancer, vinblastine can also help patients with multiple sclerosis, neuroblastoma (nb), and those that have advanced directives."
Answered by AI
How many people are taking part in this research?
"The clinicaltrials.gov website currently says that this study is looking for patients. This research was originally posted on October 13th, 2021 and the last update occurred on June 2nd, 2022. They are trying to enroll 60 individuals at a single location."
Answered by AI
What are the historical results of other research studies that have used Vinblastine?
"There are currently 1505 different clinical trials investigating the use of vinblastine. Of these, 462 have reached phase 3. While a few of the research locations for this medication are in Shanghai, there are 77266 total sites running trials worldwide."
Answered by AI
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