Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT02499952|
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : July 16, 2015
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Neoplasms Testicular Neoplasms Non Seminomatous Germ Cell Tumors Mediastinal Neoplasms Genital Neoplasms, Male Genital Neoplasms, Female Ovarian Neoplasms||Drug: Pembrolizumab||Phase 2|
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).
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:
- 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)
- 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)
- 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
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 GU14-206|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||January 13, 2017|
|Actual Study Completion Date :||January 13, 2017|
Experimental: Experimental Arm
200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Other Name: MK-3475
- 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).
Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart.
Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation.
Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.
- 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. All grade 3 and higher adverse events are reported.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499952
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Nasser Hanna, M.D.||Hoosier Cancer Research Network|