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NCT03915405 · ClinicalTrials.gov registry record · Phase 1
KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
A Phase 1 study, sponsored by Kyowa Kirin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03915405: Clinical Trial Phase 1 study, sponsored by Kyowa Kirin.
NCT03915405 is a Phase 1 study that was terminated before completion, run by Kyowa Kirin. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03915405, a Phase 1 study, was terminated before completion, sponsored by Kyowa Kirin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).
Primary Outcome
To characterize the safety and tolerability of KHK2455 administered in combination with avelumab in subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).
Interventions
- DRUG Avelumab
- DRUG KHK2455
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 1 |
Why NCT03915405 stopped before completion
NCT03915405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Avelumab is the first listed.
NCT03915405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03915405 about?
NCT03915405 is a clinical study titled "KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer". This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).
What is the current status of trial NCT03915405?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-09-26. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT03915405?
The interventions under investigation include: Avelumab (DRUG), KHK2455 (DRUG).
Who is sponsoring clinical trial NCT03915405?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03915405's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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