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Newly Diagnosed GlioblastomaPhase 2PERGOLANCT03899857

Pembrolizumab for Newly Diagnosed Glioblastoma

A Phase 2 study testing Pembrolizumab in people with Newly Diagnosed Glioblastoma, run by University of Zurich at 3 sites in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study explores the addition of pembrolizumab to temozolomide-based radiotherapy in patients with newly diagnosed glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Newly Diagnosed Glioblastoma
What is being tested?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
3 sitesSwitzerland
Study dates
21 Oct 2020to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • The patient has provided written informed consent prior to any study-related procedure.
  • Newly diagnosed glioblastoma or gliosarcoma as confirmed by local histopathology
  • The patient is at least 18 years of age on day of signing informed consent
  • Absence of isocitrate dehydrogenase (IDH)1 R132H mutation by immunohistochemistry
  • A maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreased for ≥5 days prior to start of radiotherapy
  • Patient who are treated with anticoagulants are on a stable dose for at least two weeks prior to start of radiotherapy (RT)
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  • The patient is male or a non-pregnant, non-lactating female
  • Females of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test within 2 weeks prior to receiving the first dose of study medication. Females must practice strict birth control using two different methods (e.g. oral contraceptives in combination with barrier protection) to prevent pregnancy for the duration of the study through 120 days after the last dose of study medication. Males will be advised to use barrier protection 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 an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • The patient shows adequate organ functions as assessed by the following laboratory values within 2 weeks prior to first dose of study medication:
  • Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
  • Adequate liver function with alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) < 3 times the upper limit of normal, and bilirubin value < 2.5 mg/dL
  • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within therapeutic limits (according to the medical standard at the institution)
  • Hemoglobin > 9 g/dL
  • Platelet count > 100 x 10^9/L
  • White blood count (WBC) > 3 x 10^9/L
  • Absolute neutrophil count (ANC) > 1.5 x 10^9/L
  • Patient is able to undergo Gd MRI.

Who cannot join

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to temozolomide (TMZ) or pembrolizumab,
  • 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.
  • Any known IDH mutation if tested
  • Has a diagnosis of immunodeficiency
  • Human immunodeficiency virus (HIV), hepatitis C virus (HBV) or hepatitis C virus (HCV) infection
  • Has a history of active tuberculosis (Bacillus Tuberculosis)
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  • Clinically relevant acute viral, bacterial, or fungal infection
  • History of a second independent malignant disorder during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with prostate-specific antigen (PSA) level less than upper normal limit
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, long-term use of 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.
  • Has history of, or any evidence of active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a 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
  • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, or anti-PD-L2 agent
  • Prior radiotherapy to the brain or interstitial brachytherapy
  • Prior chemotherapy for a brain tumor
  • Intraoperative placement of carmustine wafers (Gliadel®)
  • Prior therapy with immune checkpoint inhibitors or vaccination therapy against the tumor
  • Concurrent administration of any antitumor therapy other than TMZ/RT=>TMZ
  • Clinically relevant psychiatric disorders/legal incapacity or a limited legal capacity
  • Has received a live vaccine within 30 days of planned start of study therapy
  • 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.
  • Women who are pregnant or breast feeding,
  • Intention to become pregnant during the course of the study,
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
  • Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Has psychiatric or substance abuse disorders including extensive use of alcohol that would interfere with cooperation with the requirements of the trial

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • University Hospital Bern / Inselspital

    Bern

  • University Hospital Lausanne, CHUV

    Lausanne

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Pembrolizumab for Newly Diagnosed Glioblastoma: a Prospective, Open-label, Single-arm, Multicenter Phase II Study

The study explores the addition of pembrolizumab to temozolomide-based radiotherapy in patients with newly diagnosed glioblastoma.

Being tested
Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03899857
Study groupRoleWhat they receive
PembrolizumabExperimentalTemozolomide-based radiochemotherapy (TMZ/RT=>TMZ) represents the standard of care for patients with newly diagnosed glioblastoma. In this study, pembrolizumab will be administered (200 mg every 3 weeks) in addition to TMZ/RT=>TMZ.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival at 12 months

    To explore whether the addition of pembrolizumab to standard temozolomide-based radiochemotherapy improves the outcome of newly diagnosed glioblastoma or gliosarcoma patients, determined by the overall survival rate at 12 months

    Measured: At 12 months

Secondary outcomes (5)

  1. Response rates using (i)RANO (immunotherapy response assessment in neuro-oncology) criteria

    Measured: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

  2. Progression-free survival (PFS) at 6 and 12 months

    Measured: At 6 and 12 months

  3. Time to treatment failure (TTF)

    Measured: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

  4. Health-related Quality of life (HRQol)

    HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) version 3. Scoring: 0 to 100. Higher scores mean a better level of functioning.

    Measured: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

  5. Correlation of programmed cell death (PD-1) ligand 1 (PD-L1) expression levels with response to treatment and outcome

    Expression levels of PD-L1 will be determined in the tumor tissue and correlated with response as determined by MRI and progression-free as well as overall survival

    Measured: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start21 Oct 2020
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03899857
Sponsor's protocol ID
PERGOLA
Acronym
PERGOLA
Status last verified
May 2024
First submitted
6 Mar 2019
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Newly Diagnosed Glioblastoma, run by University of Zurich at 3 sites in Switzerland.

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 19 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival at 12 months (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899857.

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 8 May 2024.

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