AzTrials
AzTrials

GlioblastomaPhase 2PhenixNCT07263438

Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial

A Phase 2 study testing Trimipramine, Cohort 1: Atezolizumab and Bevacizumab in people with Glioblastoma and Recurrence Tumor, run by Centre Hospitalier Universitaire Vaudois at 7 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicentric phase II open-label clinical trial aiming to assess the efficacy of the combination of trimipramine and atezolizumab with bevacizumab in patients with recurrent glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Recurrence Tumor
What is being tested?
Trimipramine, Cohort 1: Atezolizumab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
7 sitesSwitzerland
Study dates
3 Nov 2025to 31 Dec 2030
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

  • Histologically or cytologically confirmed glioblastoma, according to World Health Organization [WHO] 2021 with unequivocal first progression after standard (6 weeks radiotherapy [RT]) with concurrent \& adjuvant temozolomide [TMZ] chemotherapy.
  • Patients must be at least 3 months off the concomitant part of chemo-radiotherapy.
  • Stable or decreasing dose of steroids for 7 days prior to the baseline
  • Magnetic Resonance Imaging [MRI] scan.
  • Maximum dose of dexamethasone (or equivalent) 4 mg at time of inclusion.
  • No surgery or other invasive procedures (major surgical procedure, open biopsy or significant traumatic injury) within 4 weeks prior to registration.
Show all 21Show fewer
  • No core biopsy or other minor surgical procedure within 7 days prior to registration. (Placement of a central vascular access device, if performed at least 2 days prior to trial treatment administration, is allowed).
  • Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs [non-EIAED]. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to registration.
  • Measurable disease per Response Assessment in Neuro-Oncology [RANO] version 2.0 criteria. Recurrent disease must be at least one bi-dimensionally measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based on MRI scan done within 28 days prior to registration.
  • Karnofsky performance status 70-100.
  • Adequate bone marrow function: neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L.
  • Adequate hepatic function: total bilirubin ≤ 1.5 x Upper Limit of Normal [ULN] (except for patients with Gilbert's syndrome ≤ 3.0 x ULN), aspartate aminotransferase [AST] and alanine transaminase [ALT] and alkaline phosphatase [AP] ≤ 2.5 x ULN.
  • Adequate renal function: estimated glomerular filtration rate [eGFR] ≥ 45 mL/min/1.73 m2 (according to Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
  • Urine dipstick for proteinuria < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein/24 hours.
  • Adequate coagulation function: International Normalized Ratio [INR] ≤ 1.5 x ULN (the ULN for INR is defined with the value 1.2 for all sites, in case no ULN is documented in the laboratory certificates/sheets). Use of full-dose anticoagulants is permitted as long as the INR is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks before registration, as per American Society for Clinical Oncology [ASCO] guidelines, low molecular weight heparin [LMWH] should be the preferred approach. Concomitant anticoagulation with aspirin (up to 300 mg/day) and anticoagulation with LMWH is allowed.
  • Women of childbearing potential must use highly effective contraception , are not pregnant or breast-feeding and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.
  • Men agree not to donate sperm or to father a child during trial treatment and until 6 months after the last dose of investigational drug.
  • Patient is able and willing to swallow trial drug as whole tablet.
  • Only for Cohort 2:
  • Consent to giving access of part of the tumor tissue and Cerebrospinal Fluid [CSF] obtained during the routine neurosurgical procedure for pharmacology and translational studies. Tumor tissue will only be made available once it is established that enough tumor tissue is available for standard neuropathological analysis.
  • Patients that have a medical indication for a neurosurgical resection from first recurrent tumor.

Who cannot join

  • Patient must be in first progression/recurrence and have not received more than one line of chemotherapy (concurrent and adjuvant temozolomide). Treatment of Time to Treatment Failure [TTF] fields (Optune®) is allowed during first line but will be stopped at registration.
  • Patients must not have prostate enlargement with urinary retention or angle-closure glaucoma at registration.
  • Any other experimental drug must be discontinued at least 30 days prior to registration
  • Patients under ongoing treatment with an antidepressant must be eligible for a switch to trimipramine. Patients currently under TriCyclic Antidepressant [TCAs] (amitriptyline, clomipramine, nortriptyline, imipramine), selective serotonin reuptake inhibitors (sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) or serotonin and norepinephrine reuptake inhibitors (venlafaxine, duloxetine) must be weaned off these medications for at least 14 days before the introduction of trimipramine.
  • Note: Patients treated with fluoxetine prior to enrollment will only be eligible for this trial after a two-month washout period before starting the study treatment.
  • Prior treatment with atezolizumab or any other immune checkpoint inhibitors.
Show all 23Show fewer
  • Prior treatment with bevacizumab or other Vascular Endothelial Growth Factor [VEGF] inhibitors or VEGF-receptor signaling inhibitors.
  • Concomitant or prior use of immunosuppressive medication within 5 half-lives before registration, with the exceptions of intranasal and inhaled corticosteroids.
  • Life expectancy of less than 12 weeks.
  • Active systemic prior malignancy. Patients with a prior malignancy (basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix) and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration.
  • Blood pressure combination treatment with more than two antihypertensive medications or uncontrolled blood hypertension under properly antihypertensive medications.
  • Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association [NYHA] III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Have a heart rate corrected QT interval using Fridericia's formula [QTcF] (QTc = QT / RR^1/3) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalaemia, familial history of long QT interval syndrome). Patients with bundle branch block and prolonged QTcF are permitted with approval of the sponsor investigator.
  • Presence of a grade 3 atrioventricular [AV] block on electrocardiogram [ECG].
  • History of cerebrovascular accident or intracranial haemorrhage within 6 months prior to registration.
  • Known history of human immunodeficiency virus [HIV] or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.
  • Known history of tuberculosis, known history of primary immunodeficiency, known history of allogeneic organ transplant. Receipt of live attenuated vaccine within 28 days prior to the first dose of atezolizumab administration. Vaccination with inactivated viruses, such as those in the influenza vaccine, are permitted.
  • History of or active auto-immune disease with the exception of diabetes mellitus type II and well controlled hypothyroidism on treatment.
  • Concomitant treatment with strong or moderate cytochrome P450 3A or 2D6 [CYP3A or CYP2D6] inducers or inhibitors.
  • Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information.
  • Monoamine oxidase inhibitors [MAOI] (Rasagiline, or others not approved in Switzerland, such as phenelzine, tranylcypromine, isocarboxazid and selegiline). Of note, MAOI must have been stopped at least 14 days prior to the start of trimipramine.
  • Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andreas Hottinger, MD, PhD contact

0041 79 556 52 71

andreas.hottinger@chuv.ch

Stéphanie Viguet-Carrin, PhD contact

0041 79 556 45 63

stephanie.viguet-carrin@chuv.ch

7 sites in 1 country

Switzerland7 sites, 7 recruiting

  • Kantonsspital Aarau

    Aarau, Canton of Aargau, 5001

    Petra Fellmann, +41 62 838 97 55, petra.fellmann@ksa.ch

    Julia Di Floriano, julia.di-floriano@ksa.ch

    Recruiting

  • Universitätsspital Basel

    Basel, Basel, 4031

    Benjamin Thiele, +41 61 328 4953, benjamin.thiele@usb.ch

    Fabienne Brutscher, fabienne.brutscher@usb.ch

    Recruiting

  • Bern Inselspital

    Bern, Canton of Bern, 3010

    Dennis Hoch, +41 79 962 93 00, dennis.hoch@insel.ch

    Manasha Pushpan Sharungan, manasha.pushpansharungan@insel.ch

    Recruiting

  • HFR Fribourg - Hôpital cantonal

    Fribourg, Canton of Fribourg, 1708

    Bianca Gautron Moura, Dr. med., +41 26 306 22 60, bianca.gautronmoura@h-fr.ch

    Jessica Lutz, jessica.lutz@h-fr.ch

    Recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

    Andreas Hottinger, PhD, MD, +41 79 556 52 71, andreas.hottinger@chuv.ch

    Stéphanie Viguet-Carrin, PhD, 0041 79 556 45 63, stephanie.viguet-carrin@chuv.ch

    Recruiting

  • Luzerner Kantonsspital

    Lucerne, Canton of Lucerne, 6000

    Christian Riklin, +41 41 205 58 73, christian.riklin@luks.ch

    Elena Bertolini, elena.bertolini@luks.ch

    Recruiting

  • Universitätsspital Zürich

    Zurich, Canton of Zurich, 8091

    Michael Weller, +41 44 255 55 00, michael.weller@usz.ch

    Marta Andrea Adorjani, martaandrea.adorjani@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Open-label Phase II Clinical Trial to Test the Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma

This is a multicentric phase II open-label clinical trial aiming to assess the efficacy of the combination of trimipramine and atezolizumab with bevacizumab in patients with recurrent glioblastoma. Eligible patients will be assigned to two cohorts depending on whether there is a medical indication for a neurosurgical resection from first recurrent tumor or not.

The aim of the cohort 1 (patients without indication for surgery) is to analyze the clinical efficacy of this triple combination in recurrent glioblastoma. 48 patients will be registered.

Read more

The aim of cohort 2 (patients with indication for surgery) is to confirm the level of trimipramine that can be achieved in the tumor tissue and cerebrospinal fluid collected during surgery. At least 5 patients will be registered.

All patients will receive the combination treatment (trimipramine and atezolizumab associated with bevacizumab) for a maximum period of 2 years from registration. The treatment schedule is slightly different for the 2 cohorts because of the neurosurgical resection foreseen for cohort 2 and the requirement to start bevacizumab only after the surgery. After the end of treatment, all patients will be followed up for safety during 90 days from first treatment administration and then up to 3 years from registration.

Being tested
Trimipramine, Cohort 1: Atezolizumab, Bevacizumab, Cohort 2: Atezolizumab, Cohort 2: Bevacizumab
Keywords
recurrent glioblastoma, trimipramine, atezolizumab, bevacizumab
Medical subject headings
Glioblastoma, Recurrence

What participants receive

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

  • TrimipramineDrug

    Trimipramine: daily oral intake at 75mg/ day for 7 days, then at 150 mg/ day

  • Cohort 1: AtezolizumabBiological

    Atezolizumab: intravenous administration at 1200 mg on the first day of 3-week cycles.

  • BevacizumabBiological

    Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles.

  • Cohort 2: AtezolizumabBiological

    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on the first day of 3-week cycles. Administration will occur once, then will be interrupted during a recovery period of 14-days post surgery, and then resumed.

  • Cohort 2: BevacizumabBiological

    Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles. The first administration will take place 5 weeks after surgery.

Study groups in NCT07263438
Study groupRoleWhat they receive
Cohort 1: Recurrent GBM without indication for re-resectionExperimentalEligible patients will receive: trimipramine, bevacizumab and atezolizumab. Trimipramine will be taken orally daily (75 mg the first week and thereafter 150 mg), bevacizumab (15 mg/kg) and atezolizumab (1200 mg) will be administered intravenously every 3 weeks. Maximum treatment duration is 2 years. Patients will undergo clinical examination, vital signs measurements, and clinical laboratory evaluations regularly. Safety events will be collected up to 90 days after treatment end. Neurological assessment, quality of life assessment, brain Magnetic Resonance Imaging [MRI] and radiological assessment with Response Assessment in Neuro-Oncology [RANO] scale as per local guidelines will be performed every 9 weeks during study treatment administrations. Thereafter, these assessments will be performed every 12 weeks until clinical or radiological recurrence, for up to 3 years after registration.
Receives: Drug: Trimipramine; Biological: Cohort 1: Atezolizumab; Biological: Bevacizumab
Cohort 2: recurrent GBm with an indication for re-resectionExperimentalEligible patients will receive: Trimipramine taken orally daily (75 mg the first week and thereafter 150 mg) and atezolizumab (1200 mg) administered intravenously. Neurosurgical resection from first recurrent tumor will be planned 1 cycle after trial treatment start. Trimipramine will be continued during surgery and recovery period (minimum 2 weeks). Atezolizumab will be re-started after a minimum recovery period of 14 days after surgery at a fixed dose of 1200 mg administered intravenously, every 3 weeks. Bevacizumab will be started one cycle after the re-start of atezolizumab, at least 35 days after surgery. It will be administered intravenously at a dose of 15 mg/kg every 3 weeks for a maximum of 32 cycles of 21 days. Patients will undergo clinical and safety follow-up up to 3 years post-registration as for Cohort 1.
Receives: Drug: Trimipramine; Biological: Cohort 2: Atezolizumab; Biological: Cohort 2: Bevacizumab

What is being measured

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

  1. Cohort 1: Progression-free survival rate [PFSR]

    Progression-free survival rate [PFSR]: evaluated at 6 months after registration using the Response Assessment in Neuro-Oncology [RANO] verion 2.0 critieria

    Measured: 6 months after last patient's registration

  2. Cohort 2: Level of trimipramine in the tumor tissue and cerebrospinal fluid [CSF]

    Level of trimipramine in the tumor tissue and CSF collected during surgery will be assessed by measuring the trimipramine concentration by laboratory analysis.

    Measured: 3 months after last patient's surgery

Timeline

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

  1. First posted4 Dec 2025
  2. Study start3 Nov 2025
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion31 Dec 2030 (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
Non-randomised
Intervention model
Parallel groups
Model description
Patients will be assigned to 2 cohorts based on whether a standard of care surgery is foreseen or not.
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07263438
Sponsor's protocol ID
CHUV- DO-Lundin-PHENIX
Acronym
Phenix
Status last verified
Feb 2026
First submitted
30 Sep 2025
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trimipramine, Cohort 1: Atezolizumab and Bevacizumab in people with Glioblastoma and Recurrence Tumor, run by Centre Hospitalier Universitaire Vaudois at 7 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 21 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Contact Andreas Hottinger, MD, PhD (0041 79 556 52 71, andreas.hottinger@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Progression-free survival rate [PFSR] (time frame: 6 months after last patient's registration). 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 NCT07263438.

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 13 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in