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NCT03317158 · ClinicalTrials.gov registry record · Phase 1
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
A Phase 1 study of Bladder Cancer and Urothelial Carcinoma, sponsored by Noah Hahn, M.D..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 12
- Study locations
NCT03317158: Recruiting Phase 1 study of Bladder Cancer and Urothelial Carcinoma, sponsored by Noah Hahn, M.D..
NCT03317158 is a Phase 1 study of Bladder Cancer and Urothelial Carcinoma that is actively recruiting participants, run by Noah Hahn, M.D.. The registered enrollment target is 55 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 12 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03317158, a Phase 1 study of Bladder Cancer and Urothelial Carcinoma, is actively recruiting participants, sponsored by Noah Hahn, M.D..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients treated with each of the following immunotherapy study regimens: Durvalumab (cohort 1) Durvalumab + intravesical BCG (cohort 2) Durvalumab + radiation (cohort 3) Durvalumab + intravesical Gemcitabine + intravesical Docetaxel (cohort 4) Durvalumab + Tremelimumab + intravesical Gemcitabine + intravesical Docetaxel (cohort 5) Intravesical NAI + intravesical Gemcitabine (coho
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT03317158 shows while recruiting
NCT03317158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
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.
NCT03317158 lists 12 locations in 12 states (Arizona, California, Illinois).
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.
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).
Who is sponsoring clinical trial NCT03317158?
This trial is sponsored by Noah Hahn, M.D., which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03317158's enrollment target sits among peer trials
55 107th of 175 higher than 68 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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