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Durvalumab for Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fox Chase Cancer Center, Philadelphia, PABladder Cancer+1 MoreDurvalumab - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is for a treatment for bladder cancer. It will test different combinations of drugs, some with BCG and some without. If the side effects from a certain combination are too severe, that combination will not be used.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 14 Secondary · Reporting Duration: 2 years (24 months)

12 month
Phase 1: Characterize the 12-month recurrence free survival (RFS) rate of BCG-unresponsive NMIBC subjects treated with each study regimen
12 months
Phase 2: Determine the 12-month RFS rate in BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naive NMIBC subjects treated with each study regimen
Phase 2: Determine the 12-month RFS rate within individual phase 2 expansion cohorts of BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naive NMIBC subjects treated with each study regimen
Phase 2: Identify significant associations between complete response rates and 12-month RFS rates and baseline tumor immunohistochemistry staining patterns of PD-L1 and other relevant mechanism of action targets for each study regimen
2 years (24 months)
Phase 1: Characterize the complete response rate of BCG-unresponsive NMIBC subjects treated with each study regimen
6 months
Phase 1: Assess Adverse Events
Phase 1: Characterize the 6-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy monotherapy or doublet combinations
Phase 1: Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
BCG Vaccine
Phase 2: Assess Adverse Events
Phase 2: Determine the 6-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with durvalumab
Phase 2: Determine the 6-month relapse-free survival (RFS) rates of BCG-relapsing or persistent non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy doublet combinations or BCG re-treatment
Phase 2: Determine the complete response rate in BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naïve NMIBC subjects treated with each study regimen
Phase 2: Determine the complete response rate within individual phase 2 expansion cohorts of BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naïve NMIBC subjects treated with each study regimen
up to 24 months
Assess the safety profile of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy monotherapy or doublet combinations by reporting the highest grade adverse event per patient, as assessed by CTCAE v4.0.
Assess the safety profile of subjects treated with immunotherapy monotherapy, doublet combinations or BCG re-treatment by reporting the highest grade adverse event per patient as assessed by CTCAE v4.0.
Phase 2: Determine the 24-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with durvalumab.
Phase 2: Determine the 24-month relapse-free survival (RFS) rates of BCG-relapsing or persistent non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy doublet combinations or BCG re-treatment
Phase 2: Identify significant associations between 6- and 24-month RFS rates and baseline tumor immunohistochemistry staining patterns of PD-L1 and other relevant mechanism of action targets for each drug studied within each study arm.

Trial Safety

Safety Progress

1 of 3

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1
Treatment with Adoptive Cell Therapy
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Trial Design

10 Treatment Groups

Phase 2: (cohort 2a), (cohort 2b), & (BCG re-treatment)
1 of 10
Phase 1: (cohort 1):
1 of 10
Phase 1: Cohort 4
1 of 10
Phase 1: Cohort 6
1 of 10
Phase 2: Cohort 4 Expansion
1 of 10
Phase 1: Cohort 3
1 of 10
Phase 1: Cohort 2
1 of 10
Phase 1: Cohort 1
1 of 10
Phase 1: Cohort 5
1 of 10
Phase 1: (cohort 2a) & (cohort 2b):
1 of 10

Experimental Treatment

55 Total Participants · 10 Treatment Groups

Primary Treatment: Durvalumab · No Placebo Group · Phase 1 & 2

Phase 2: (cohort 2a), (cohort 2b), & (BCG re-treatment)Experimental Group · 3 Interventions: External Beam Radiotherapy (EBRT), Durvalumab, Bacillus Calmette-Guérin (BCG) · Intervention Types: Radiation, Drug, Biological
Phase 1: (cohort 1):
Drug
Experimental Group · 1 Intervention: Durvalumab · Intervention Types: Drug
Phase 1: Cohort 4Experimental Group · 3 Interventions: Docetaxel, Durvalumab (Cohort 4/5), Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase 1: Cohort 6
Other
Experimental Group · 1 Intervention: To be determined · Intervention Types: Other
Phase 2: Cohort 4 ExpansionExperimental Group · 3 Interventions: Docetaxel, Durvalumab (Cohort 4/5), Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase 1: Cohort 3Experimental Group · 2 Interventions: Durvalumab (Cohort 1-3), External Beam Radiotherapy (EBRT) · Intervention Types: Drug, Radiation
Phase 1: Cohort 2Experimental Group · 2 Interventions: Durvalumab (Cohort 1-3), Bacillus Calmette-Guérin (BCG) · Intervention Types: Drug, Biological
Phase 1: Cohort 1
Drug
Experimental Group · 1 Intervention: Durvalumab (Cohort 1-3) · Intervention Types: Drug
Phase 1: Cohort 5Experimental Group · 4 Interventions: Tremelimumab, Docetaxel, Durvalumab (Cohort 4/5), Gemcitabine · Intervention Types: Biological, Drug, Drug, Drug
Phase 1: (cohort 2a) & (cohort 2b):Experimental Group · 3 Interventions: External Beam Radiotherapy (EBRT), Durvalumab, Bacillus Calmette-Guérin (BCG) · Intervention Types: Radiation, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3480
Docetaxel
1995
Completed Phase 4
~5670
Gemcitabine
2017
Completed Phase 3
~2070
Durvalumab
FDA approved
Bacillus Calmette-Guérin (BCG)
2014
Completed Phase 2
~1070

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years (24 months)

Who is running the clinical trial?

Hoosier Cancer Research NetworkOTHER
66 Previous Clinical Trials
3,605 Total Patients Enrolled
Noah Hahn, M.D.Lead Sponsor
4 Previous Clinical Trials
223 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,021 Previous Clinical Trials
240,381,399 Total Patients Enrolled
Noah M. Hahn, MDStudy ChairHoosier Cancer Research Network

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You should be able to perform daily activities without assistance or with some limitations.
You must be at least 18 years old to participate.
Your white blood cell count must be at least 3.0 K/mm3 or higher.
You need to have at least 100,000 platelets per cubic millimeter of blood.
Your hemoglobin level should be at least 9 grams per deciliter (g/dL).
Your blood test for bilirubin (a substance produced by the liver) is within a normal range.
You have been diagnosed with non-muscle invasive urothelial carcinoma of the bladder (stages Ta, T1, or Tis) within the past 60 days through a biopsy known as TURBT.
You have a specific type of bladder cancer called urothelial carcinoma, and have had a biopsy to confirm the diagnosis. If you have had the tumor removed and it did not invade the muscle layer of the bladder, you are eligible to participate as long as the re-resection was done within the last 60 days and you meet all other criteria.
Your blood test shows that you have enough infection-fighting white blood cells (ANC) in your body, with a count of at least 1.5 K/mm3.
Your liver enzymes (ALT and AST) should not be more than 2.5 times the upper limit of normal.
References

Frequently Asked Questions

What positive results is this research hoping to achieve?

"This clinical trial, which is slated to run for 6 months or so, has two primary objectives. The first aims to identify the Recommended Phase 2 Dose from BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Additionally, associations between Complete Response Rate and 12 Month Relapse Free Survival Rates will be determined by analysing Baseline Tumor Immunohistochemistry Staining Patterns of PD-L1 as well as other pertinent Mechanisms of Action Targets. Lastly, the safety profile of NMIBC patients treated within each regimen studied will be assessed via NCI Common Terminology Criteria for" - Anonymous Online Contributor

Unverified Answer

Is enrollment still open in this research protocol?

"Affirmative. According to the information stored on clinicaltrials.gov, this medical trial is presently seeking participants; it was originally posted in November 2017 and most recently modified in October 2022. 186 individuals need to be recruited from 7 distinct medical centres." - Anonymous Online Contributor

Unverified Answer

How widespread is the implementation of this research project in our city?

"There are 7 trial sites recruiting participants. For example, UNC Chapel Hill in North Carolina, Indiana University's Melvin and Bren Simon Cancer Center in Indianapolis, the University of Iowa Hospitals & Clinics located in Iowa City - plus four other venues." - Anonymous Online Contributor

Unverified Answer

In what clinical scenarios is Durvalumab typically recommended?

"Durvalumab has been approved as a viable treatment for unresectable stage III non-small cell lung cancer, untreated metastatic urothelial carcinoma, and other conditions." - Anonymous Online Contributor

Unverified Answer

What is the cap on how many participants can join this clinical trial?

"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants across 7 sites since it was first made available on November 21st 2017 and recently updated October 31st 2022. At present, 186 individuals need to be enrolled in the trial overall." - Anonymous Online Contributor

Unverified Answer

Could you provide a synopsis of the past experiments done with Durvalumab?

"At present, 333 clinical trials are active for Durvalumab. Of these studies, 52 have progressed to Phase 3. There is a heavy concentration of research sites in Cordoba, Texas; however, the medication is being explored at numerous locations across 12952 cities and towns." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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