Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

NCT02779101 | Unknown Phase 2

• 1 other identifier: PCNSL01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In summary, there is a high medical need for patients suffering from recurrent/progressive PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the treatment of these patients.

Conditions

Primary Central Nervous System Lymphoma

Keywords

Central nervous system lymphoma; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Response assessment

  Response assessment will be performed according to modified IPCG response criteria on contrast-enhanced cranial MRI-scans

  after 24 month

Secondary Outcomes (2)

• Clinical adverse events

  after 24 month

• Laboratory parameters

  after 24 month

Study Arms (1)

Single arm

EXPERIMENTAL

pembrolizumab

Drug: pembrolizumab

Interventions

pembrolizumab DRUG

Pembrolizumab 200 mg every 3 weeks

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Minimum of 18 years of age on day of signing informed consent.
• Histologically confirmed diagnosis of PCNSL (DLBCL) at initial diagnosis
• The patient has a Karnofsky performance status of at least 50%.
• Documented progression or recurrence in cranial MRI after prior MTX-based first-line therapy (with or without prior radiotherapy)
• Measurable disease in cranial MRI (lesion size \>10x10mm)
• Is not pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• Female patient of childbearing potential has a negative urine or serum pregnancy test within 24 hours of first pembrolizumab infusion. lf the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
• The patient has a life expectancy of at least 3 months.
• The patient has a Karnofsky performance status of at least 50%.
• The patient demonstrates adequate organ function
• Patient is able to undergo Gadolinium-MRI

You may not qualify if:

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• Concurrent administration of any other antitumor therapy except steroids
• Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has active infection requiring systemic therapy.
• Known history of active TB (Bacillus Tuberculosis)
• Known history of, or any evidence of active, non-infectious pneumonitis.
• Has received a live vaccine within 30 days of planned start of study therapy.
• o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
• Drug abuse or extensive use of alcohol.
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
• Positive human immunodeficiency virus (HIV) test and a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• History of allergy to study drug components and no history of severe hypersensitivity reaction to any monoclonal antibody.
• Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1.

Sponsors & Collaborators

• Prof. Dr. Matthias Preusser: lead

Study Sites (1)

Dept of Internal Medicine

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Matthias Preusser, MD

  MU Vienna, Dep. f. Internal medicine I, Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Preusser, MD

CONTACT

+43140400; matthias.preusser@meduniwien.ac.at

Marika Rosner

CONTACT

+43140400; marika.rosner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

AU (1)