Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Ovarian Neoplasms

Mediastinal Neoplasms

Genital Neoplasms, Female

Testicular Neoplasms

Genital Neoplasms, Male

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Thoracic Neoplasms

Mediastinal Diseases

Thoracic Diseases

Respiratory Tract Diseases

Ovarian Cancer

Germ Cells Tumors

Nonseminomatous Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Nasser Hanna, M.D.

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.

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

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

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.

Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.

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

Hoosier Cancer Research Network

Merck Sharp & Dohme LLC

Sponsor-Investigator

Pembrolizumab

Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Experimental Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Location Of Primary Tumor

Tumor Histology

Predominant Histology

Number of Previous Chemotherapy Regimens

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead

ECOG Performance Status

Retroperitoneum

Pulmonary

Non Pulmonary Visceral Metastasis

The overall count of metastatic location(s). Subjects may have metastasis at multiple locations.

Metastatic Site(s)

This study was terminated early due to not meeting the primary efficacy endpoint at a pre-planned interim analysis.

Clinical Data Coordinator

Clinical Benefit Rate (CBR)

Skin and subcutaneous tissue disorders

Noncardiac chest pain

Anemia

Sciatic pain

Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.

Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria

Disease Assessment for Duration of Disease Response

Overall Study

Spots Global Cancer Trial Database for non seminomatous germ cell tumors