NCT02437370

Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer

Feasibility Trial of MK3475 + Docetaxel or Gemcitabine in Platinum Pre-treated Urothelial Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of MK-3475 (pembrolizumab) when given in combination with docetaxel or gemcitabine (gemcitabine hydrochloride) in patients with advanced or metastatic platinum-treated urothelial cancer. SECONDARY OBJECTIVES: I. To assess in a preliminary manner the efficacy of this combination (overall response rate and progression free survival). II. To determine in an exploratory manner programmed death (PD)-ligand (L)1 expression in archival tumor specimens and to correlate this with patient outcomes. OUTLINE: This is a dose-escalation study of pembrolizumab. Patients are assigned to 1 of 2 treatment arms. (Patients who had received prior gemcitabine hydrochloride/cisplatin or gemcitabine hydrochloride/carboplatin \[GC\] or methotrexate, vinblastine sulfate, adriamycin, and cisplatin \[MVAC\] therapy are assigned to Arm A). ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and docetaxel IV over 60 minutes on day 1. ARM B: Patients receive pembrolizumab IV as in Arm A and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. In both arms, treatment repeats every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 6 months.

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

Type	Name	Description
DRUG	Pembrolizumab	Given IV
DRUG	Docetaxel	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-08-07
• Completion: 2020-03-10
• First posted: 2015-05-07
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States