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NCT03240016 · ClinicalTrials.gov registry record · Phase 2
Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT03240016: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT03240016 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03240016, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.
Primary Outcome
The Overall Response Rate (ORR) will be the percentage of patients that achieve either complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions
Interventions
- DRUG Pembrolizumab
- DRUG Abraxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2023-06-23 |
| Phase | Phase 2 |
What the finished NCT03240016 record still lists
NCT03240016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03240016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03240016 about?
NCT03240016 is a clinical study titled "Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer". This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. ...
What is the current status of trial NCT03240016?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2018-02-08. Estimated completion is 2023-06-23.
What interventions are being tested in trial NCT03240016?
The interventions under investigation include: Pembrolizumab (DRUG), Abraxane (DRUG).
Who is sponsoring clinical trial NCT03240016?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03240016's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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