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NCT03451331 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer
A Phase 2 study, sponsored by Matthew Galsky.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT03451331: Completed Phase 2 study, sponsored by Matthew Galsky.
NCT03451331 is a Phase 2 study that has completed, run by Matthew Galsky. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03451331, a Phase 2 study, has completed, sponsored by Matthew Galsky.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic status.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the percentage of patients who achieve a response (confirmed PR or CR) according to
Interventions
- DRUG Carboplatin
- DRUG Oxaliplatin
- DRUG Nivolumab
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 2 |
What the finished NCT03451331 record still lists
NCT03451331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT03451331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03451331 about?
NCT03451331 is a clinical study titled "Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer". This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic ...
What is the current status of trial NCT03451331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2018-05-10. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT03451331?
The interventions under investigation include: Carboplatin (DRUG), Oxaliplatin (DRUG), Nivolumab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03451331?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03451331's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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