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Platinum-containing compounds
Durvalumab + Chemo/Radiation for Bladder Cancer
Phase 2
Waitlist Available
Led By Monika Joshi
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
Patient must not have received any previous radiation therapy to the pelvic area
Adequate renal function as evidenced by calculated (Cockcroft's formula) creatinine clearance or 24 hours actual creatinine clearance >= 30mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing if adding the immunotherapy drug durvalumab to standard chemotherapy and radiation therapy helps treat bladder cancer that has spread to the lymph nodes better than standard chemotherapy and radiation therapy alone.
Who is the study for?
This trial is for adults with bladder cancer that has spread to lymph nodes but not elsewhere. They must have good physical function, no prior pelvic radiation, and acceptable blood counts and organ function. HIV-positive patients on effective therapy can join. Those with a history of certain cancers or autoimmune diseases, active infections like tuberculosis or hepatitis, or who are pregnant cannot participate.Check my eligibility
What is being tested?
The INSPIRE study is testing if adding the immunotherapy drug Durvalumab to standard chemotherapy (Cisplatin) and radiation improves treatment response in bladder cancer that's reached lymph nodes. The goal is to see if this combination helps shrink tumors better than chemo and radiation alone.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues, fatigue, infusion reactions, potential worsening of pre-existing autoimmune conditions, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had radiation therapy to my pelvic area.
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My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.
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My cancer has spread to the lymph nodes but not to distant parts of the body.
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My tests after initial treatment show no advanced bladder cancer.
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My bladder cancer is confirmed to be urothelial type.
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I can care for myself and am up and about more than 50% of my waking hours.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical complete response (CR)
Secondary outcome measures
Bladder cancer specific survival
Bladder-intact event-free survival (BI-EFS)
Complete response duration
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Step 2, Arm E (durvalumab)Experimental Treatment6 Interventions
Patients previously randomized to Arm C (chemoradiation and durvalumab) who achieve clinical CR or clinical benefit receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Step 1, Arm C (durvalumab, radiation therapy, chemotherapy)Experimental Treatment11 Interventions
Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity.
Group III: Step 1, Arm D (radiation therapy, chemotherapy)Active Control10 Interventions
Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity.
Group IV: Step 2, Arm F (observation)Active Control6 Interventions
Patients previously randomized to Arm D (chemoradiation) who achieve clinical CR or clinical benefit, or patients previously randomized to Arm C with no clinical CR or clinical benefit undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Mitomycin
2009
Completed Phase 3
~410
Biospecimen Collection
2004
Completed Phase 2
~1700
Durvalumab
2017
Completed Phase 2
~3870
Computed Tomography
2017
Completed Phase 2
~2720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Fluorouracil
2014
Completed Phase 3
~11540
Cystoscopy
2016
Completed Phase 4
~810
Cisplatin
2013
Completed Phase 3
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,276 Total Patients Enrolled
Monika JoshiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any live vaccines in the last 30 days.You have a history of a weak immune system from birth.I do not have serious liver disease.I haven't had an autoimmune disease in the last 2 years.I agree to have a CT scan for treatment planning.I have or had inflammatory bowel disease.I have a history of cancer.I have never had radiation therapy to my pelvic area.I meet the criteria for adjuvant durvalumab treatment.I have had or currently have pneumonitis.My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.I don't have lasting side effects from cancer treatment.I do not have an active infection like TB or Hepatitis B/C.Your platelet count is at least 100,000 per microliter.Your AST and ALT levels are not more than 2.5 times the normal limit at the study site.Your bilirubin levels are within the normal range for the hospital where you are being treated.I haven't had any cancer except for skin cancer in the last 5 years.My cancer has spread to the lymph nodes but not to distant parts of the body.Your hemoglobin level is 9 grams per deciliter or higher.I have a heart condition and have been assessed using the NYHA classification.I do not have active tumors in my upper urinary tract or urethra.You have enough infection-fighting white blood cells in your body.I have had a condition where my lymphocytes grow abnormally.My tests after initial treatment show no advanced bladder cancer.I have HIV but am on effective treatment with an undetectable viral load.My bladder cancer is confirmed to be urothelial type.I am on the chemoRT+ durvalumab treatment plan.I haven't taken any immunosuppressive drugs in the last 14 days.I can care for myself and am up and about more than 50% of my waking hours.I have been treated with immune checkpoint inhibitors for a non-muscle invasive condition.Your white blood cell count is at least 3,000 per microliter.I am 18 years old or older.I have another cancer type, but it won't affect this cancer treatment's safety or results.
Research Study Groups:
This trial has the following groups:- Group 1: Step 1, Arm C (durvalumab, radiation therapy, chemotherapy)
- Group 2: Step 1, Arm D (radiation therapy, chemotherapy)
- Group 3: Step 2, Arm E (durvalumab)
- Group 4: Step 2, Arm F (observation)
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 there numerous locations where this research is being conducted within the US?
"85 select medical centres across the country are hosting this clinical trial. Of these, there are locations near Stevens Point, Weston and Atlanta. To best accommodate your needs as a potential study participant, it is crucial to identify an institution close by when enrolling in the program."
Answered by AI
What is the participant limit for this research endeavor?
"This medical trial necessitates the enrolment of 102 participants that meet distinct inclusion criteria. There are two sites where patients can join, namely Marshfield Medical Center-River Region at Stevens Point in Stevens Point, Georgia and Marshfield Medical Center - Weston in Weston, Illinois."
Answered by AI
Are there any historical instances of Radiation Therapy being employed in clinical studies?
"Radiation Therapy was initially studied in 1997 at Spectrum Health Hospital - Butterworth Campus and has since been tested a total of 3969 times. Currently, there are 2319 live studies taking place, the majority of which can be found located in Stevens Point, Georgia."
Answered by AI
What maladies can be remedied with Radiation Therapy?
"Radiation Therapy is an effective treatment for small cell lung cancer (sclc), advanced testicular cancer, and neuroblastoma (nb)."
Answered by AI
What is the Federal Drug Administration's stance on Radiation Therapy?
"Our team has assessed the security of Radiation Therapy to be a 2, as there is evidence that it does not pose an excessive risk but no clinical data demonstrating its efficacy."
Answered by AI
Is this research the inaugural endeavor of its type?
"At the moment, 2319 ongoing clinical trials for Radiation Therapy are in progress across 91 countries and 4360 cities. The first such trial was sponsored by Alfacell in 1997 and it included 300 participants who completed Phase 3 of the drug approval process. Subsequently, 3969 studies were finished since then."
Answered by AI
Are there vacancies remaining in this research project?
"The clinicaltrials.gov website indicates that recruitment for this research is still ongoing. It was posted on August 25th 2020, with the most recent changes being made on November 12th 2022."
Answered by AI
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