Clinical Trial: Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief 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 Summary:
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)
Sponsor: Nasser Hanna, M.D.
Current Primary Outcome: Clinical Benefit Rate (CBR) [ Time Frame: up to 18 weeks ]
CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC).
Original Primary Outcome: Disease Assessment for Overall Response Rate (ORR) by Immune Related Response Criteria [ Time Frame: up to 18 weeks ]
ORR of single agent pembrolizumab in subjects with refractory GCTs - determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC).
Current Secondary Outcome:
- Number of participants with adverse events as a measure of safety and tolerability using Common Terminology Criteria for Adverse Events (CTCAE) V4. [ Time Frame: Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks ]Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs.
- Disease assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria [ Time Frame: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks ]ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria
- Disease assessment for duration of disease response [ Time Frame: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks ]Duration of disease response
Original Secondary Outcome:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability by CTCAE v4 [ Time Frame: Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks ]Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs.
- Disease Assessment for Overall Response Rate (ORR) by RECIST 1.1 Criteria [ Time Frame: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks ]ORR of single agent pembrolizumab in subjects with refractory GCTs - determined by sum of complete responses, partial responses, and stable disease for at least 3 months using RECIST 1.1 criteria
- Disease assessment for duration of disease response [ Time Frame: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks ]Duration of disease response
Information By: Hoosier Cancer Research Network
Dates:
Date Received: July 8, 2015
Date Started: January 2016
Date Completion: January 31, 2019
Last Updated: February 1, 2017
Last Verified: February 2017
- Number of participants with adverse events as a measure of safety and tolerability using Common Terminology Criteria for Adverse Events (CTCAE) V4. [ Time Frame: Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks ]
