NCT02500121

Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer

A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.

Detailed description

OUTLINE: This is a multi-center trial. Eligible subjects will be 1:1 randomized to placebo (Control Arm A) and pembrolizumab (Experimental Arm B). Stratification factors for randomization: presence of visceral metastatic disease (lung, liver, or bone or other organs vs. lymph node only) at the time of initiation of first-line chemotherapy, and response to first-line chemotherapy (CR/PR vs. SD. Subjects who progress on placebo will be assessed to determine if they are eligible to cross over to unblinded treatment with pembrolizumab. INVESTIGATIONAL TREATMENT: For Control Arm A, commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline. For Experimental Arm B, pembrolizumab (or placebo), 200 mg intravenous infusion (IV) every 3 weeks for up to 12 months, or until progressive disease (PD) or unacceptable toxicity. The following required laboratory values must be obtained within fourteen days prior to registration for protocol therapy: Hematopoietic: * Absolute neutrophil count (ANC) ≥1,500 /mcL * Platelets ≥100,000 / mcL * Hemoglobin ≥8.5 g/dL Renal: * Creatinine ≤1.5x ULN OR * Measured or calculated creatinine clearance ≥30 mL/min for subject with creatinine levels \>1.5x institutional ULN * GFR can also be used in place of creatinine or CrCl Hepatic: * Serum total bilirubin ≤ 1.5 X ULN OR * Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN * AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subject with liver metastases Coagulation: * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN. If subject is on anticoagulant therapy, PT or PTT must be within therapeutic range of intended use of anticoagulants.

Conditions

• Urothelial Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Placebo	Normal saline
DRUG	Pembrolizumab	Pembrolizumab, 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or for up to 24 months

Timeline

• Start date: 2015-11-11
• Primary completion: 2019-07-01
• Completion: 2021-01-01
• First posted: 2015-07-16
• Last updated: 2022-09-30
• Results posted: 2022-09-30

Locations

28 sites across 1 country: United States