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Pembrolizumab and Nab Paclitaxel in Patients With Metastatic Urothelial Carcinoma

NCT03464734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-11-30

No results posted yet for this study

Summary

This phase II, single-center study will assess the efficacy of pembrolizumab + nab-paclitaxel in patients who have metastatic urothelial tumor and do not respond to chemotherapy. The time between drug administration and progression of the disease will be assessed to determine if the drug will work.

Conditions

  • Metastatic Urothelial Carcinoma

Interventions

DRUG

Pembrolizumab and Nanoparticle Albumin-bound Paclitaxel

At study entry, patients will receive 2 cycles of pembrolizumab at the dose of 200 mg, intravenously in 30 min, on day 1 and nab-paclitaxel 125 mg/m2 intravenously in 30-40 min, on day 1 and 8.

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-01-21
Completion
2020-01-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03464734 on ClinicalTrials.gov