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Vaccine

Immunotherapy + Chemotherapy for Bladder Cancer (ADAPT-BLADDER Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Noah Hahn, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic, hepatic, and renal function as defined by specific laboratory parameters

Age ≥ 18 years old at time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years (24 months)

Awards & highlights

ADAPT-BLADDER Trial 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.

Who is the study for?

Adults with non-muscle invasive bladder cancer confirmed within the last 60 days, who are generally healthy and have good organ function. They must not have other active cancers (except certain skin or prostate cancers), severe medical conditions, or be pregnant/breastfeeding. Participants need to use contraception and agree to follow study rules.Check my eligibility

What is being tested?

The trial is testing Durvalumab alone or in combination with treatments like EBRT, Gemcitabine, Docetaxel, Tremelimumab, and BCG for bladder cancer. It starts with Durvalumab; if safe, it adds other treatments. Patients join different groups based on availability and choice of radiation participation.See study design

What are the potential side effects?

Durvalumab can cause immune-related inflammation in organs, infusion reactions similar to allergic responses when receiving the drug through a vein, fatigue, potential liver issues (hepatitis), lung problems (pneumonitis), hormone gland disorders (like thyroid issues), and increased infection risk.

ADAPT-BLADDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, liver, and kidney tests are within normal ranges.

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I am 18 years old or older.

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I am fully active or can carry out light work.

ADAPT-BLADDER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years (24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years (24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)

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

Secondary outcome measures

Phase 1: Assess Adverse Events

Phase 1: Characterize the 12-month recurrence free survival (RFS) rate of BCG-unresponsive NMIBC subjects treated with each study regimen

Phase 1: Characterize the complete response rate of BCG-unresponsive NMIBC subjects treated with each study regimen

+3 more

Side effects data

From 2017 Phase 2 trial • 989 Patients • NCT02075203

10%

Injection site pain

Upper respiratory tract infection

Headache

Fatigue

Myalgia

Injection site swelling

Nausea

Arthralgia

Injection site warmth

Injection site erythema

Chills

Blood pressure systolic increased

White blood cell count increased

Blood pressure increased

Conjunctivitis

Diarrhoea

Neutrophil count increased

Lymphadenopathy

Pharyngitis

Gastritis

Varicella

Haemoglobin decreased

Proteinuria

Pyrexia

Platelet count increased

Haematuria

Vomiting

Pyelonephritis

Rash

Dysmenorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

AERAS-404 (15 mcgH4/500 Nmol IC31)

Bacillus Calmette-Guerin (BCG)

ADAPT-BLADDER Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 2: Cohort 4 ExpansionExperimental Treatment3 Interventions

Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc) The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.

Group II: Phase 1: Cohort 6Experimental Treatment1 Intervention

Additional Regimens (to be determined)

Group III: Phase 1: Cohort 5Experimental Treatment4 Interventions

NOTE: Cohort 5 was abandoned prior to any patients enrolled. Durvalumab + Tremelimumab + Gem/Doc The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments. For the intravenous medications, durvalumab should be administered first followed by tremelimumab.

Group IV: Phase 1: Cohort 4Experimental Treatment3 Interventions

Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc) The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.

Group V: Phase 1: Cohort 3Experimental Treatment2 Interventions

Durvalumab plus External Beam Radiotherapy (EBRT) (BCG re-treatment) - Cross-over to Durvalumab Monotherapy

Group VI: Phase 1: Cohort 2Experimental Treatment2 Interventions

Durvalumab plus BCG

Group VII: Phase 1: Cohort 1Experimental Treatment1 Intervention

Durvalumab monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Docetaxel

1995

Completed Phase 4

~5620

Tremelimumab

2017

Completed Phase 2

~3380

Bacillus Calmette-Guérin (BCG)

2014

Completed Phase 2

~1980

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoosier Cancer Research NetworkOTHER

68 Previous Clinical Trials

3,700 Total Patients Enrolled

Noah Hahn, M.D.Lead Sponsor

4 Previous Clinical Trials

223 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,275 Previous Clinical Trials

288,613,546 Total Patients Enrolled

Media Library

Bacillus Calmette-Guérin (BCG) (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03317158 — Phase 1 & 2

Bladder Cancer Clinical Trial 2023: Bacillus Calmette-Guérin (BCG) Highlights & Side Effects. Trial Name: NCT03317158 — Phase 1 & 2

Bladder Cancer Research Study Groups: Phase 1: Cohort 4, Phase 1: Cohort 5, Phase 2: Cohort 4 Expansion, Phase 1: Cohort 3, Phase 1: Cohort 2, Phase 1: Cohort 1, Phase 1: Cohort 6

Bacillus Calmette-Guérin (BCG) (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03317158 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder

Noah Hahn, M.D. 2017. "Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03317158.

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