18 and older, any sex, with Transitional Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· Up to 6 months
The overall response rate will be performed in all patients that are evaluable for efficacy and will have one interim analysis. Overall response is complete response (CR) = Disappearance of all target lesions (PR) = at least a 30% decrease in sum of diameters, taking as reference the baseline sum diameters; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters while on study; and progressive disease (PD) = at least a 20% increase in the sum of diameters of target lesions, taking as reference th
Group
Value
95% CI
Treatment (Pembrolizumab, Paclitaxel)
3
Treatment (Pembrolizumab, Paclitaxel)
6
Treatment (Pembrolizumab, Paclitaxel)
9
Treatment (Pembrolizumab, Paclitaxel)
7
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Secondary· Up to 1 year
All adverse events will be tabulated and presented by preferred term and/or system organ class and grade. All deaths and serious adverse events will be tabulated.
Serious adverse events
Group
Value
95% CI
Treatment (Pembrolizumab, Paclitaxel)
34
Adverse events
Group
Value
95% CI
Treatment (Pembrolizumab, Paclitaxel)
61
Progression Free Survival (Kaplan Meier Method)Secondary· At 6 months
The Kaplan Meier methods will be used to estimate progression free survival. The 6-month PFS will be compared to historical rates using a chi-square test. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)
Group
Value
95% CI
Treatment (Pembrolizumab, Paclitaxel)
44
26 – 62
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients with urothelial cancer that has not responded to previous treatment and has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together with pembrolizumab may be an effective treatment for urothelial cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other recruiting trials for Transitional Cell Carcinoma
Currently open trials in the same condition.
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Other Wake Forest University Health Sciences trials
Trials by the same sponsor.
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· not yet recruiting
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· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 10 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02581982.