NCT02499952

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors

A Phase II Single-Arm Multi-Center Trial Evaluating the Efficacy of Pembrolizumab in the Treatment of Subjects With Incurable Platinum-Refractory Germ Cell Tumors: Hoosier Cancer Research Network GU14-206

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nasser Hanna, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in patients with incurable platinum refractory germ cell tumors. No randomization or blinding is involved.

Detailed description

OUTLINE: This is a multi-center study. Eligible subjects must have received initial cisplatin-based combination therapy, such as bleomycin-etoposide-cisplatin (BEP), cisplatin-etoposide (EP), etoposide-ifosfamide-cisplatin (VIP), or similar regimens AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm, such as high dose chemotherapy, paclitaxel-ifosfamide-cisplatin (TIP), or vinblastine-ifosfamide-cisplatin (VeIP). INVESTIGATIONAL TREATMENT: Pembrolizumab 200mg IV every 3 weeks until progression or toxicity. Treatment will continue for up to 52 weeks in the absence of prohibitive toxicities or disease progression. The following screening labs to demonstrate adequate organ function must be performed within 10 days of treatment initiation: Hematological: * Absolute neutrophil count (ANC) ≥1,500 /mcL * Platelets ≥100,000 / mcL * Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or hematopoietin (EPO) dependency (within 7 days of assessment) Renal: * Serum creatinine ≤1.5 X upper limit of normal (ULN) OR * Measured or calculated creatinine clearance ≥60 mL/min for subject with creatinine levels \>1.5 X institutional ULN * Glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (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 subjects with liver metastases * Albumin \>2.5 mg/dL Coagulation: * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Conditions

• Germ Cell Neoplasms
• Testicular Neoplasms
• Non Seminomatous Germ Cell Tumors
• Mediastinal Neoplasms
• Genital Neoplasms, Male
• Genital Neoplasms, Female
• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-13
• Completion: 2017-01-13
• First posted: 2015-07-16
• Last updated: 2022-07-11
• Results posted: 2018-04-17

Locations

2 sites across 1 country: United States