GlioblastomaPhase 1/2STERIMGLINCT02866747
A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma
A Phase 1/2 study testing Hypofractionated stereotactic radiation therapy and Durvalumab in people with Glioblastoma, run by Institut Claudius Regaud at 10 sites in France.
Trial summary
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part. The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Hypofractionated stereotactic radiation therapy and Durvalumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Jan 2017to 2 Nov 2024
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years at time of study entry.
- Previous histopathologic confirmation of glioblastoma.
- Any line of recurrence of glioblastoma proven by contrast enhanced MRI within 28 days prior to the first fraction of RT, per modified RANO criteria (Wen et al JCO 2010).
- Note: Recurrence is defined as progression following therapy (i.e., chemotherapy, radiation, second surgery).
- Recurrent nodule of an histologically confirmed diagnosis of World Health Organization (WHO) Grade IV malignant glioma (Glioblastoma) occurring in or out the previous irradiation fields.
- Recurrent disease documented by MRI evidence with a size of the recurrence evaluated on T1 post-gadolinium sequence ≤35mm.
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- Patient for which a re-irradiation (by hFSRT) has been decided by the multidisciplinary medical board.
- Patients with measurable disease.
- Prior radiotherapy must be ended at least 12 weeks before the first fraction of RT (unless progressive disease outside of the radiation field or histopathologic confirmation of unequivocal tumor to eliminate pseudoprogression images according to RANO recommendations, Wen et al JCO 2010).
- In case of previous anti-VEGF/VEGFR targeted therapy: at least 28 days between the last injection of anti-VEGF/VEGFR targeted therapy and the first fraction of RT.
- Karnofsky performance status ≥70.
- Adequate hematologic, renal and hepatic function, as defined below:
- Absolute Neutrophil Count ≥ 1500/mm3
- Haemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm3
- Total bilirubin ≤ 1.5 x ULN (for patient with confirmed Gilbert's syndrome,
- Total bilirubin ≤ 3 x ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min, using the Cockcroft-Gault formula:
- Female CrCl = (140 - age in years) x weight in kg x 0.85 /72 x serum creatinine in mg/dL
- Male CrCl = (140 - age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL
- Female Patients must either be of non-reproductive potential (i.e., post-menopausal by history: ≥60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Written informed consent and any locally required authorization (e.g., Social security for France (Health Insurance)) obtained from the patient prior performing any protocol-related procedures, including screening evaluations.
- Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Multifocal GBM recurrence (exception: multisite nodular recurrence (maximum: 2 sites) that can be irradiated by hFSRT according to investigator's judgement).
- Distance between tumor and optic ways including chiasma or brainstem <1 cm.
- Prior re-irradiation (except if fulfilling the following requirements: ended at least 6 months before the first fraction of RT in the study, localized outside the target of interest for the trial, and previously re-irradiated lesion controlled at the time of study entry).
- Prior exposure to Durvalumab or other anti-PD-1, anti-PD-L1, anti-CTLA4 antibodies.
- Patient who received a live vaccine within 30 days prior to the first fraction of RT.
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within 28 days prior to the first fraction of RT.
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- Current or prior use of immunosuppressive medication within 10 days before the first fraction of RT (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) - Topical, inhaled, nasal and ophthalmic steroids are not prohibited).
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
- Presence of diffuse leptomeningeal disease or extracranial disease.
- Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener's granulomatosis and Hashimoto's thyroiditis).
- Note: participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll.
- Known primary immunodeficiency or active HIV.
- Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or hepatitis C virus antibody.
- History of organ transplant requiring use of immunosuppressive medication.
- History of active tuberculosis.
- Current pneumonitis or interstitial lung disease.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses.
- Other invasive malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only.
- History of severe allergic reactions to any unknown allergens or any components of the study drug.
- Any prior Grade ≥ 3 immune-related adverse event (irAE) or any prior corticosteroid-refractory irAE.
- Participation in any other clinical trial involving another investigational product within 4 weeks prior to the first fraction of RT.
- Participation in any other clinical trial which delivered a dose >60 Gy for the primo-treatment for glioblastoma.
- Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing highly effective method of birth control.
- Any condition that, in the clinical judgment of the investigator, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
- Mental impairment (psychiatric illness/social situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut de Cancerologie de L'Ouest
Angers, 49055
Hopital Avicenne
Bobigny, 93 000
Centre Francois Baclesse
Caen, 14 000
Centre Georges Francois Leclerc
Dijon, 21 000
Institut Regional Du Cancer de Montpellier
Montpellier, 34 298
Hopital Pitie Salpetriere
Paris, 75013
Institut Curie
Saint-Cloud, 92 210
Centre Paul Strauss
Strasbourg, 67000
Institut Claudius Regaud
Toulouse
Institut Gustave Roussy
Villejuif, 94 800
About this study
Official title: A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.
The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.
Read more
Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:
- Arm A (control arm): Radiation therapy alone
- Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab
- Conditions
- Glioblastoma
- Being tested
- Hypofractionated stereotactic radiation therapy, Durvalumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated stereotactic radiation therapyRadiation
DurvalumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: radiation therapy alone | Active comparator | Hypofractionated stereotactic radiation therapy (hFSRT) 24 Gray (Gy), 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 of the radiotherapy (RT), Day 3 RT and Day 5 RT. Receives: Radiation: Hypofractionated stereotactic radiation therapy |
| Arm B: combined treatment | Experimental | hFSRT 24 Gy, 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 RT, Day 3 RT and Day 5 RT, combined with Durvalumab infusion: first administration of Durvalumab* on Day 5 RT (i.e. the same day after the last fraction of radiation, corresponding to the Day 1 for Durvalumab treatment) and then administration of Durvalumab 1500 milligrams (mg) every four weeks.
* Dosing 750 mg or 1500 mg, according to the recommended combination schema determined in phase I. Receives: Radiation: Hypofractionated stereotactic radiation therapy; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose Limiting Toxicities (DLT) incidence
For each patient of the phase I part, DLT incidence will be evaluated until one month after the last radiotherapy fraction.
Measured: 8 months
Phase II: overall survival
Measured: 36 months post randomization
Secondary outcomes (10)
Phase I and II: Intracranial progression-free interval
Intracranial progression-free interval is defined by the time from inclusion (for phase I) or randomization (for phase II) to local or distant (outside the re-irradiated volume) progression. Patients without progression at last follow-up news are censored at this date.
Measured: 27 months
Phase I: Safety and tolerability according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03
Measured: 19 months
Phase I and II: Quality of life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ C30).
Measured: 27 months
Phase I and II : Quality of life using the using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Brain Neoplasm (QLQ-BN20).
Measured: 27 months
Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Neuro-Oncology (NANO) scale.
Measured: 27 months
Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Montreal Cognitive Assessment (MoCA) tests.
Measured: 27 months
Phase II: Time to Quality of Life (QoL) deterioration.
Time to QoL deterioration is defined as the time interval between randomization and first decrease in QoL score greater or equal to 5 points. Patients without such a QoL decrease will be censored at last follow-up news or at initiation of a new therapeutic strategy.
Measured: 27 months
Phase II: time to neurocognitive deterioration
Time to neurocognitive deterioration is defined as the time interval between randomization and first of 3 points difference in MoCA as minimal clinically important difference. Patients without such a neurocognitive decrease will be censored at last follow-up news or at initiation of a new therapeutic strategy.
Measured: 27 months
Phase II: Immune-related intracranial progression-free interval
Immune-related intracranial progression-free interval is defined by the time from randomization to local or distant (outside the re-irradiated volume) progression (based on immunotherapy Response Assessment for Neuro-Oncology iRANO). Patients without progression at last follow-up news are censored at this date.
Measured: 27 months
Phase II: Acute and late toxicities according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start17 Jan 2017
- Primary completion2 Nov 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866747
- Sponsor's protocol ID
- 16TETE04
- Acronym
- STERIMGLI
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2016
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pouessel D, Ken S, Gouaze-Andersson V, Piram L, Mervoyer A, Larrieu-Ciron D, Cabarrou B, Lusque A, Robert M, Frenel JS, Uro-Coste E, Olivier P, Mounier M, Sabatini U, Sanchez EH, Zouitine M, Berjaoui A, Cohen-Jonathan Moyal E. Hypofractionated Stereotactic Re-irradiation and Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results. Oncologist. 2023 Sep 7;28(9):825-e817. doi: 10.1093/oncolo/oyad095.
PubMed 37196069
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)
- ClinicalTrials.gov ID
- NCT02866747
- Acronym / sponsor ID
- STERIMGLI / 16TETE04
- Conditions
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 15 Aug 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.
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.
The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.
Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:
- Arm A (control arm): Radiation therapy alone
- Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: radiation therapy alone | Active comparator | Radiation: Hypofractionated stereotactic radiation therapyHypofractionated stereotactic radiation therapy (hFSRT) 24 Gray (Gy), 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 of the radiotherapy (RT), Day 3 RT and Day 5 RT. |
| Arm B: combined treatment | Experimental | Radiation: Hypofractionated stereotactic radiation therapy, Drug: DurvalumabhFSRT 24 Gy, 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 RT, Day 3 RT and Day 5 RT, combined with Durvalumab infusion: first administration of Durvalumab* on Day 5 RT (i.e. the same day after the last fraction of radiation, corresponding to the Day 1 for Durvalumab treatment) and then administration of Durvalumab 1500 milligrams (mg) every four weeks. * Dosing 750 mg or 1500 mg, according to the recommended combination schema determined in phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years at time of study entry.
- Previous histopathologic confirmation of glioblastoma.
- Any line of recurrence of glioblastoma proven by contrast enhanced MRI within 28 days prior to the first fraction of RT, per modified RANO criteria (Wen et al JCO 2010).
- Note: Recurrence is defined as progression following therapy (i.e., chemotherapy, radiation, second surgery).
- Recurrent nodule of an histologically confirmed diagnosis of World Health Organization (WHO) Grade IV malignant glioma (Glioblastoma) occurring in or out the previous irradiation fields.
Key exclusion criteria (26 listed)
- Multifocal GBM recurrence (exception: multisite nodular recurrence (maximum: 2 sites) that can be irradiated by hFSRT according to investigator's judgement).
- Distance between tumor and optic ways including chiasma or brainstem <1 cm.
- Prior re-irradiation (except if fulfilling the following requirements: ended at least 6 months before the first fraction of RT in the study, localized outside the target of interest for the trial, and previously re-irradiated lesion controlled at the time of study entry).
- Prior exposure to Durvalumab or other anti-PD-1, anti-PD-L1, anti-CTLA4 antibodies.
- Patient who received a live vaccine within 30 days prior to the first fraction of RT.
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 |
|---|---|---|
| Hypofractionated stereotactic radiation therapy | Radiation | Arm A: radiation therapy alone, Arm B: combined treatment |
| Durvalumab | Drug | Arm B: combined treatment |
Primary outcome
Phase I: Dose Limiting Toxicities (DLT) incidence
Time frame: 8 months
For each patient of the phase I part, DLT incidence will be evaluated until one month after the last radiotherapy fraction.
Phase II: overall survival
Time frame: 36 months post randomization
10 secondary outcomes
Phase I and II: Intracranial progression-free interval
Time frame: 27 months
Phase I: Safety and tolerability according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03
Time frame: 19 months
Phase I and II: Quality of life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ C30).
Time frame: 27 months
Phase I and II : Quality of life using the using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Brain Neoplasm (QLQ-BN20).
Time frame: 27 months
Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Neuro-Oncology (NANO) scale.
Time frame: 27 months
Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Montreal Cognitive Assessment (MoCA) tests.
Time frame: 27 months
Phase II: Time to Quality of Life (QoL) deterioration.
Time frame: 27 months
Phase II: time to neurocognitive deterioration
Time frame: 27 months
Phase II: Immune-related intracranial progression-free interval
Time frame: 27 months
Phase II: Acute and late toxicities according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03
Time frame: 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 37196069Pouessel D, Ken S, Gouaze-Andersson V, Piram L, Mervoyer A, Larrieu-Ciron D, Cabarrou B, Lusque A, Robert M, Frenel JS, Uro-Coste E, Olivier P, Mounier M, Sabatini U, Sanchez EH, Zouitine M, Berjaoui A, Cohen-Jonathan Moyal E. Hypofractionated Stereotactic Re-irradiation and Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results. Oncologist. 2023 Sep 7;28(9):825-e817. doi: 10.1093/oncolo/oyad095.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypofractionated stereotactic radiation therapy and Durvalumab in people with Glioblastoma, run by Institut Claudius Regaud at 10 sites in France.
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 24 inclusion and 26 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: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase I: Dose Limiting Toxicities (DLT) incidence (time frame: 8 months). The study lists 2 primary outcomes in all. 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 NCT02866747, which also lists 1 linked publication.
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 14 Apr 2026.