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Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL) | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

Open-label Single Arm Phase II Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

NCT02779101•Prof. Dr. Matthias Preusser

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.

Detailed Description

The objective of this study are: PRIMARY OBJECTIVES * To evaluate the Overall Response Rate (CR/PR) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy * To evaluate the safety of pembrolizumab in subjects diagnosed with recurrent PCNSL SECONDARY OBJECTIVES * To describe Best Overall Response categories (CR, PR, SD, PD) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy * To describe individual duration of response over time * To assess progression-free survival in this patient population * To assess overall survival in this patient population EXPLORATORY OBJECTIVES * To assess PD-L1 as a predictive marker for response to pembrolizumab

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
•Has no diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion.
•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.
+5 more criteria

Exclusion Criteria

•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.
+12 more criteria

Locations (1)

Dept of Internal Medicine

Vienna, Austria

Key Dates

Start Date

June 1, 2016

Primary Completion Date

June 1, 2018

Completion Date

June 1, 2019

Last Updated

June 22, 2016

Enrollment

ESTIMATED participants

Conditions

Primary Central Nervous System Lymphoma

Interventions

pembrolizumab

DRUG

Contacts

Matthias Preusser, MD

CONTACT

+43140400 matthias.preusser@meduniwien.ac.at

Marika Rosner

CONTACT

+43140400 marika.rosner@meduniwien.ac.at

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CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL