Primary Central Nervous System LymphomaPhase 2NCT02779101
Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
A Phase 2 study testing pembrolizumab in people with Primary Central Nervous System Lymphoma, run by Prof. Dr. Matthias Preusser at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2016to Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
- 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
Who cannot join
- 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.
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- 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.
- Has not recovered (i.e.Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Known hypersensitivity to pembrolizumab or any of its excipients.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Single Arm Phase II Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
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.
Read the 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
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- pembrolizumab
- Keywords
- Central nervous system lymphoma, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumabDrug
Pembrolizumab 200 mg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | pembrolizumab Receives: Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response assessment
Response assessment will be performed according to modified IPCG response criteria on contrast-enhanced cranial MRI-scans
Measured: after 24 month
Secondary outcomes (2)
Clinical adverse events
clinical adverse Events will be assessed by CTCAE v4.0
Measured: after 24 month
Laboratory parameters
adverse events due to laboratory parameters will be assessed by CTCAE v4.0
Measured: after 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Matthias Preusser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Matthias Preusser, Medical University of Vienna
- Investigators
- Matthias Preusser, MD, Principal investigator, MU Vienna, Dep. f. Internal medicine I, Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779101
- Sponsor's protocol ID
- PCNSL01
- Status last verified
- Jun 2016
- First submitted
- 17 May 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Single Arm Phase II Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
- ClinicalTrials.gov ID
- NCT02779101
- Acronym / sponsor ID
- PCNSL01
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Central nervous system lymphoma, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Prof. Dr. Matthias PreusserUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: pembrolizumabpembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumabPembrolizumab 200 mg every 3 weeks | Drug | Single arm |
Primary outcome
Response assessment
Time frame: after 24 month
Response assessment will be performed according to modified IPCG response criteria on contrast-enhanced cranial MRI-scans
2 secondary outcomes
Clinical adverse events
Time frame: after 24 month
Laboratory parameters
Time frame: after 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Preusser, MD principal investigator
MU Vienna, Dep. f. Internal medicine I, Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pembrolizumab in people with Primary Central Nervous System Lymphoma, run by Prof. Dr. Matthias Preusser at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Preusser, MD (+43140400 ext. 44450, matthias.preusser@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response assessment (time frame: after 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016; AzTrials last refreshed its copy on 26 Oct 2026.