Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 38
Summary
- 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
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 preliminar...
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.
Tracking Information
- NCT #
- NCT02437370
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Primo Lara University of California, Davis
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