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GlioblastomaPhase 3SONOBIRDNCT05902169

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

A Phase 3 study testing SonoCloud-9 (SC9), Carboplatin and Lomustine in people with Glioblastoma and Recurrent Glioblastoma, run by CarThera at 56 sites in 11 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Recurrent Glioblastoma, GBM
What is being tested?
SonoCloud-9 (SC9), Carboplatin and Lomustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
56 sitesin 11 countries
Study dates
29 Jan 2024to 30 Jun 2028
Phase
Phase 3
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 proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.
  • Patient must have received prior first line therapy that must have contained both:
  • Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction, ≥56 Gy<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen)
  • One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)
  • First, unequivocal disease progression with
  • measurable tumor (>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI and,
Show all 50Show fewer
  • interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling
  • Patient is a candidate for craniotomy and at least 50% resection of enhancing region
  • Maximal enhancing tumor diameter prior to inclusion ≤ 5 (+7%) cm on T1w on MRI performed within 14 days prior to inclusion§. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm)
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70)
  • Age ≥ 18 years
  • Participant must be recovered from acute toxic effects (≤ grade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least:
  • ≥ 4 weeks or 5 half-lives (whichever is shorter) for
  • Cytotoxic
  • Other small chemical entity (e.g., targeted therapy)
  • For biologics (e.g., antibodies, except bevacizumab)
  • ≥ 6 weeks of prior bevacizumab
  • Adequate hematologic, hepatic, and renal laboratory values within 14 days prior to inclusion§ i.e.:
  • Hemoglobin ≥ 10 g/dL, platelets ≥ 100,000/mm3, neutrophils ≥ 1500/mm3.
  • Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome
  • Estimated glomerular filtration rate (eGFR) of at least 60 mL/min/m2 using Appendix 12.4 formula
  • AST(SGOT)/ALT(SPGT) ≤ 3 X institutional ULN (upper Limit of Normal)
  • Patient able to understand clinical trial information and willing to provide signed and informed consent
  • Patient of childbearing potential must have a negative pregnancy test within 14 days prior to inclusion§ and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin
  • A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period.
  • Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements)
  • (§) These exam/lab tests could be (re)evaluated before randomization if the corresponding selection criteria could not be fully met at time of inclusion. If not met before randomization, the patient will be considered as screen failure.
  • Non-Inclusion Criteria:
  • Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter area)
  • Posterior fossa tumor
  • Known BRAF/ NTKR mutated patients
  • Patient at risk of surgery site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, known impaired wound healing and/or previously infected surgical field, uncontrolled diabetes or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)
  • Patient treated at high, stable -or average- dose of corticosteroids (≥ 6 mg/day dexamethasone or equivalent) in the 7 days prior to inclusion. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • Contra-indication to carboplatin, CCNU or TMZ
  • Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in ultrasound resonator
  • Patient has received bevacizumab for other reasons (such as tumor progression) than treating edema
  • Peripheral neuropathy or neuropathy ≥ grade 2
  • Uncontrolled epilepsy or evidence of intracranial pressure
  • Patient with known intracranial aneurism or having presented intra-tumor significant spontaneous hemorrhage
  • Patient with unremovable coils, clips, shunts, intravascular stents, and/or wafer, or reservoirs
  • Patient with medical need to be on continued anti-platelet aggregation therapy and/or anticoagulation. Patients for whom anticoagulation/platelet aggregation can be temporarily interrupted may be eligible after discussion and prior authorization by the sponsor.
  • Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin, carbamazepine and derivatives, phenobarbital), unless switched on another antiepileptic regimen
  • History of other malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
  • Patient with known or suspected active or chronic infections
  • Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory distress syndrome
  • Known sensitivity/allergy to gadolinium, or other intravascular contrast agents
  • Patient with impaired thermo-regulation or temperature sensation
  • Pregnant, or breastfeeding patient
  • Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus [HIV] status, potential blood-borne infections, malnutrition…), circumstance (e.g., sinus opening during surgery), psychological, morphological characteristics (e.g., skin characteristics, bone thickness), or any pre-existing comorbidities that in the investigator's opinion may prevent the implantation of the device, may impair the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical trial endpoints
  • Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision

Who cannot join

  • Occurrence of any major medical illnesses or impairments that in the Investigator's opinion may hampered the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical endpoints.

Trial locations and contacts

56 sites in 11 countries.

56 sites in 11 countries

United States23 sites

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

  • UCHealth

    Aurora, Colorado, 80011

  • John Hopkins University

    Baltimore, Maryland, 21287

  • University of North Carolina

    Chapel Hill, North Carolina, 27516

  • Northwestern University

    Chicago, Illinois, 60611

  • Neurological Institute Brain Tumor Centre Taussig Cancer Cente

    Cleveland, Ohio, 44106

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Texas Houston Health Science Center

    Houston, Texas, 77030

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • Mayo Clinic of Jacksonville Florida

    Jacksonville, Florida, 32224

  • Kaiser Permanente

    Los Angeles, California, 90027

  • UCLA

    Los Angeles, California, 90095

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Weill Cornell Medicine

    New York, New York, 10021

  • NewYork-Presbyterian / Columbia University Irving Medical Center

    New York, New York, 10032

  • Lennox Hill Hospital

    New York, New York, 10075

  • Mayo Clinic Arizona

    Phoenix, Arizona, 805054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Utah, Hunstman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sutter Health - California Pacific Medical Center

    San Francisco, California, 94109

  • University of California, San Francisco

    San Francisco, California, 94143

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Germany6 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Neurochirurgie uniklinik Köln

    Cologne

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Essen Klinik für Neurologie

    Essen, 45147

  • University Hospital Munster

    Münster, 48149

Other trials in Germany

Italy6 sites

  • Ospedale Bellaria

    Bologna, 40139

  • Ospedale Civile di Livorno

    Livorno, 57124

  • Istituto Oncologico Veneto

    Padua

  • IFO - Istituto Nazionale Tumori Regina Elena

    Roma

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

  • Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Spain5 sites

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

France4 sites

  • Hôpital Neurologique Pierre Wertheimer

    Bron

  • Hôpital de La Timone

    Marseille

  • Hôpital de la Pitié-Salpêtrière

    Paris

  • Hôpital Foch

    Suresnes, 92150

Other trials in France

Belgium3 sites

  • Universitair Ziekenhuis Brussel

    Brussels

  • Universitair Ziekenhuis Leuven

    Leuven

  • CHU de Liège

    Liège

Other trials in Belgium

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Netherlands2 sites

  • Erasmus Medisch Centrum (Erasmus MC)

    Rotterdam

  • Haaglanden Medisch Centrum

    The Hague, 2263

Other trials in Netherlands

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

Switzerland2 sites

  • Inselspital Bern

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

Other trials in Switzerland

Austria1 site

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Being tested
SonoCloud-9 (SC9), Carboplatin, Lomustine, Temozolomide
Keywords
carboplatin, SonoCloud, blood-brain barrier, Low Intensity Pulsed Ultrasound (LIPU)
Medical subject headings
Glioblastoma

What participants receive

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

  • SonoCloud-9 (SC9)Device

    Implantation of SC9 device and repeat activation at constant acoustic pressure

  • CarboplatinDrug

    Also called CycloButane DiCarboxylic Acid (CBDCA)

    Dose of carboplatin AUC 5 mg/ml.min-1 calculated using Calvert's formula:

    Dose (mg) = target AUC (mg/mL x minute) x [glomerular filtration rate (GFR) mL/minute + 25].

  • LomustineDrug

    Also called 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU)

    Dosed and administered per labelling.

  • TemozolomideDrug

    Also called Temodal

    Dosed and administered per labelling.

Study groups in NCT05902169
Study groupRoleWhat they receive
Experimental Arm: SonoCloud-9 Ultrasound + CarboplatinExperimentalThe SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Receives: Device: SonoCloud-9 (SC9); Drug: Carboplatin
Control Arm: SoC single agent chemotherapy TMZ or CCNUActive comparatorStandard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU). Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles. Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
Receives: Drug: Lomustine; Drug: Temozolomide

What is being measured

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

  1. Overall survival (OS)

    Survival status will be collected during the treatment period, for up to 7 months (short-term follow-up) and then every 3 months as standard of care follow-up (long-term follow-up) until participant's 'End of Study', defined as end of survival follow-up period, death, withdrawal of consent for the collection of data, or 'lost to follow-up' (whichever comes first).

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Tumor Growth Rate

    Tumor Growth Rate will be determined by measuring hyperintense tumor volume using T1w contrast-enhancing tumor-related region from post-surgery MRI baseline to unequivocal progression MRI (i.e., suspected radiologic progression confirmed by repeat scan).

    Measured: Up to week 24

  2. Progression Free Survival (PFS)

    Defined as the time from date of randomization to the earlier of the following events: unequivocal tumor progression as determined by IRC per RANO criteria or death due to any cause.

    Measured: Up to 24 months

  3. Overall survival at 12 months (OS12)

    Defined as the proportion of participants alive at 12 months

    Measured: 12 months

  4. Overall survival at 18 months (OS18)

    Defined as the proportion of participants alive at 18 months

    Measured: 18 months

  5. Progression-free survival at 6 months (PFS6)

    Defined as the proportion of participants without disease progression or death due to any cause at 6 months.

    Measured: 6 months

Timeline

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

  1. First posted13 Jun 2023
  2. Study start29 Jan 2024
  3. Primary completion28 Jan 2028 (estimated)
  4. Study completion30 Jun 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902169
Sponsor's protocol ID
SC9-GBM-03
Other IDs
2023-505829-14-00, 2023
Acronym
SONOBIRD
Status last verified
Aug 2026
First submitted
5 Jun 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

    PubMed 27306666

  • Sonabend AM, Gould A, Amidei C, Ward R, Schmidt KA, Zhang DY, Gomez C, Bebawy JF, Liu BP, Bouchoux G, Desseaux C, Helenowski IB, Lukas RV, Dixit K, Kumthekar P, Arrieta VA, Lesniak MS, Carpentier A, Zhang H, Muzzio M, Canney M, Stupp R. Repeated blood-brain barrier opening with an implantable ultrasound device for delivery of albumin-bound paclitaxel in patients with recurrent glioblastoma: a phase 1 trial. Lancet Oncol. 2023 May;24(5):509-522. doi: 10.1016/S1470-2045(23)00112-2.

    PubMed 37142373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SonoCloud-9 (SC9), Carboplatin and Lomustine in people with Glioblastoma and Recurrent Glioblastoma, run by CarThera at 56 sites in 11 countries.

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 50 inclusion and 1 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Germany, Italy, Spain, France and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (OS) (time frame: Up to 24 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 NCT05902169, which also lists 2 linked publications.

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 5 Nov 2026.

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