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Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer

NCT02437370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-10-18

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of pembrolizumab when given together with docetaxel or gemcitabine hydrochloride in treating patients with previously treated urothelial cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or that has spread from the primary site (place where it started) to other places in the body (metastatic). Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, 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. Giving pembrolizumab together with docetaxel or gemcitabine hydrochloride may be a better treatment for urothelial cancer.

Conditions

  • Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Recurrent Bladder Carcinoma
  • Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Regional Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Stage III Bladder Urothelial Carcinoma
  • Stage III Urethral Cancer
  • Stage IV Bladder Urothelial Carcinoma
  • Stage IV Urethral Cancer
  • Urethral Urothelial Carcinoma

Interventions

DRUG

Pembrolizumab

Given IV

DRUG

Docetaxel

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

Sponsors & Collaborators

Principal Investigators

  • Primo Lara · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2019-08-07
Completion
2020-03-10

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02437370 on ClinicalTrials.gov