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RECRUITING Phase 1

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

NCT03317158 · View on ClinicalTrials.gov ↗

Study Summary

Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to combination regimen cohorts will proceed. Cohorts will simultaneously enroll in parallel to each other with patients assigned to cohorts based on patient slot availability and study site choice of radiation arm participation. Patient assignment to future phase 1 arms would proceed similarly. Within BCG-containing cohorts, treatment will begin at full-dose BCG. If DLT criteria outlined in Section 5.1.4 are exceeded with full-dose BCG, a one level dose reduction of BCG will be implemented. If DLT criteria outlined in Section 5.1.4 are exceeded with reduced-dose BCG, the BCG-containing cohort will not proceed to Phase 2 of the study. Similarly, if DLT criteria outlined in Section 5.1.4 are exceeded within non-BCG containing cohorts, the non-BCG containing cohort will not proceed to phase 2 of the study. Due to the prolonged half-life of antibody therapies, no dose adjustments are planned for durvalumab in any of the cohorts.

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine
  • DRUG Durvalumab (Cohort 1-3)
  • RADIATION External Beam Radiotherapy (EBRT)
  • BIOLOGICAL Bacillus Calmette-Guérin (BCG)

Study Locations (12)

Arizona

  • BCG Oncology — Phoenix

California

  • Stanford University — Stanford

Illinois

  • Rush University Medical Cneter — Chicago

Indiana

  • Indiana University Melvin and Bren Simon Cancer Center — Indianapolis

Iowa

  • University of Iowa Hospitals and Clinics — Iowa City

Maryland

  • Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center — Baltimore

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2017-11-21
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Noah Hahn, M.D.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03317158

The ClinicalTrials.gov registry entry for NCT03317158 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noah Hahn, M.D., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03317158 reports 12 study locations spanning 12 distinct geographic areas — top geographies include Arizona, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03317158 about?

NCT03317158 is a clinical study titled "Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder". Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to comb...

What is the current status of trial NCT03317158?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2017-11-21. Estimated completion is 2026-12-31.

What conditions does trial NCT03317158 study?

This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03317158?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), Durvalumab (Cohort 1-3) (DRUG), External Beam Radiotherapy (EBRT) (RADIATION), Bacillus Calmette-Guérin (BCG) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03317158?

This trial is sponsored by Noah Hahn, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03317158 being conducted?

This trial has 12 study locations across Arizona, California, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial