Primary GlioblastomaPhase 2MATVAC-1NCT07347210
Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma
A Phase 2 study testing UCPVax, Pembrolizumab and Temozolomide in people with Primary Glioblastoma, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial summary
Glioblastomas (GBM) are the most frequent brain tumors and one of the most lethal adult cancers despite maximal multimodal therapy. Despite maximal safe resection followed by radiotherapy and temozolomide (TMZ) ± tumor-treating fields, median overall survival for newly diagnosed GBM remains around 18 months and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Glioblastoma
- What is being tested?
- UCPVax, Pembrolizumab and Temozolomide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2026to Jul 2029
- 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
- Male or female, age ≥ 18 with informed consent signed
- Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy).
- Tumor with unmethylated MGMT promoter status
- Patients having completed the concomitant phase of radiotherapy + temozolomide regimen (standard radiotherapy with 60 Gy in 30 fractions or hypofractionated radiotherapy with 40 Gy in 15 fractions), and eligible for the 6 monthly cycles of maintenance temozolomide
- Karnofsky Perfomance status (KPS) ≥ 70%
- Life expectancy ≥ 3 months
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- If patient is treated by corticosteroïds (CS), patient must be on stable CS dose for 15 days and total daily dose ≤ 10 mg prednisone, or equivalent
- Adequate organ function laboratory values
- Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :
- Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
- Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.
- Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but tubal ligation.
- Female with childbearing potential must use effective contraception during study treatment and after the end of treatment based on the last study drug administrated: 6 months after the last dose of Temozolomide; 4 months after the last dose of pembrolizumab and 1 month after the last injection of UCPVax.
- Male patients with a female partner of childbearing potential should be willing to use barrier contraception and to refrain from donating sperm during the study and and post-treatment based on the last study drug administrated: 3 months after the last dose of temozolomide; 4 months after the last pembrolizumab dose; 1 month after the last UCPVax injection.
- Patient affiliated to or beneficiary of French social security system
- Ability to comply with the study protocol, in the Investigator's judgment.
- Signed and dates informed consent
Who cannot join
- Patients will not be eligible for this study for any of the following reasons:
- Cancer specific exclusion criteria:
- IDH1 or IDH2 mutated tumor
- Presence of extracranial metastasis
- Leptomeningeal disease on MRI
- Contrast enhancement ≥4 cm (largest diameter on axial T1 sequences) on inclusion MRI
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- Previous treatment with Carmustine impregnated wafers (GliadelR)
- Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.
- Non-eligible to treatment by UCPVax:
- Prior therapy with an anti-PD-1, anti-PD-L1, or with an agent directed to another immune checkpoint (e.g. CTLA-4, TIGIT, Lag3…).
- Immunosuppressive treatment including CS > 10 mg prednisone or equivalent within the previous 2 weeks
- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- History of tuberculosis infection
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Active auto-immune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroïds or immunosuppressors). Replacement therapy (e.g. thyroxine, insulin) is allowed.
- Active or history of auto-immune disease or immune deficiency
- History of solid organ transplant nor allogenic hematopoietic stem cell transplantation
- Hypersensitivity to the active substance temozolomide or to any of the excipients listed (anhydrous lactose, colloidal anhydrous silica, sodium carboxymethyl starch type A, tartaric acid, stearic acid),
- Hypersensitivity to dacarbazine (DTIC)
- Hypersensitivity to the active substance pembrolizumab or to any of the excipients listed (L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E433))
- Hypersensitivity to the active substance Montanide
- Uncontrolled active systemic fungal, bacterial, viral, or other infection within the previous 4 weeks or requirement for intravenous (IV) antibiotics within the last two weeks
- Inadequate hematology and organ functions; known cardiac failure or unstable coronaropathy, respiratory failure or another life threatening condition.
- Patient with unresolved non-hematologic toxicities > Grade 1 (or > Grade 2 if deemed acceptable by the investigator and not considered a safety risk)
- Major surgery within 1 month prior randomization or planned during the study
- Vaccination with alive attenuated vaccine within 4 weeks prior the first dosing. Patient must agree not to receive live attenuated vaccine including influenza vaccine during the treatment and within 6 months following the last dose of pembrolizumab
- Non-eligible to a clinical trial:
- Diagnosis of another malignant tumor within 2 years before randomization except treating resected basocellular carcinoma and carcinoma in situ such as breast cancer, endometrial or cervical carcinoma that have undergone curative therapy.
- Current or treatment with another investigational drug within the previous 4 weeks.
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists (up to 4 months after end of chemotherapy)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CHU de Besançon
Besançon
Clotilde VERLUT, Dr
Clotilde VERLUT, Dr
Centre Georges François Leclerc
Dijon
François GHIRINGHELLI, Pr
François GHIRINGHELLI, Pr
CHU La Timone
Marseille
Emeline TABOURET, Dr
Emeline TABOURET, Dr
Hôpital Saint-Louis - APHP
Paris
Antoine CARPENTIER, Pr
Antoine CARPENTIER, Pr
About this study
Official title: Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma: a Randomized Phase II Trial
Glioblastomas (GBM) are the most frequent brain tumors and one of the most lethal adult cancers despite maximal multimodal therapy. Despite maximal safe resection followed by radiotherapy and temozolomide (TMZ) ± tumor-treating fields, median overall survival for newly diagnosed GBM remains around 18 months and long-term survival is rare, and recurrence is nearly universal. So, the development of new therapeutic strategies is a critical unmet need in GBM.
Despite the limited success of anti-PD(L)-1 therapy, immunotherapy remains a promising option in GBM. Current challenge supports to develop combinatorial therapy approaches considering the particular immune tumor microenvironment in GBM. Anticancer vaccines have shown promising signs of efficacy in GBM but critical factors challenge their efficacy. CD4 T help is of major interest for cancer vaccine effectiveness and for immune checkpoint inhibitors success. We previously designed UCPVax a CD4 T helper-targeted cancer vaccine derived from telomerase (TERT), a very attractive GBM-associated antigen (Adotévi O, J Clin Oncol 2023 ; Laheurte C, Cell Report Med 2025). The induction of robust tumor reactive CD4 T cell response with UCPVax together with TMZ-mediated immune effects will promote recruitment of effectors immune cells into tumor bed creating a more suitable microenvironment for anti-PD-1 action.
This is a proof-of-concept phase II trial to evaluate the efficacy of maintenance therapy evaluating UCPVax +/- pembrolizumab combined to standard treatment in newly diagnosed unmethylated MGMT glioblastoma. A translational research network will be implemented to better understand the therapeutic efficacy of this combination.
- Conditions
- Primary Glioblastoma
- Being tested
- UCPVax, Pembrolizumab, Temozolomide
- Keywords
- GBM, UCPVax, pembrolizumab, cancer vaccine, telomerase, CD4 T cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCPVaxDrug
Priming : UCPVax (two helper peptides UCP2 and UCP4 + Montanide ISA51) at 0.5 mg subcutaneously at day 1, 8, 15, 29, 36 and 43
Boost : UCPVax at 0.5 mg subcutaneously one month after priming and then every 8 weeks for 12 months maximum
PembrolizumabDrug
400 mg/m1 every 6 weeks since day 1 until disease progression or unacceptable toxicity for a maximum of 1 year
TemozolomideDrug
150-200 mg/m2/day x 5 days per month x 6 months according to best standard of care starting at day 1 of week 1 (with vaccine 1 of UCPVax).
Additional treatment with NOVO-TTF200A will be allowed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A | Experimental | UCPVax + Pembrolizumab + Standard of care Receives: Drug: UCPVax; Drug: Pembrolizumab; Drug: Temozolomide |
| Experimental Arm B | Experimental | UCPVax + Standard of care Receives: Drug: UCPVax; Drug: Temozolomide |
| Control Arm C | Other | Standard of care Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the experimental arm with UCPVax +/- pembrolizumab combined with standard treatment (Temozolomide +/- Novo-TTF-200A)
Rate for patients alive at 18 months post-randomization
Measured: 18 months
Secondary outcomes (8)
Assessment of the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the control arm receiving standard treatment( Temozolomide +/- NovoTTF-200A)
The rate of patients alive at 18 months post randomization
Measured: 18 months
Assessment of the Overall Survival (OS) in the three arms
Overall survival (OS) defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period
Measured: from date of randomization until date of death from any cause, assessed up to 42 months
Assessment of the progression free survival (PFS) since randomization in the three arms
Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up.
Measured: From date of randomization until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 42 months
Assessment of the progression free survival (PFS) at 6 months since randomization in the three arms
Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up.
Measured: 6 months
Evaluation of incidence of treatment-emergent adverse events in the three arms
Adverse events and routine lab abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness and relationship to study treatments at each visit.
Measured: up to 42 months
Assessment of the immunogenicity of the proposal combination therapy.
UCP specific TCD4 T-cell response will be assess by ex vivo IFN-γ ELISpot in peripheral blood (Adotevi JCO 2023).
Measured: average of 30 months
Evaluation of health-related quality of life (HrQoL) in the two arms
Health related Quality of life will be evaluated with EORTC-QLQC30 questionnaire and BN20 module at randomization and at 6 months.
Measured: up to 42 months
Exploratory biomarker study
Measured: average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary GlioblastomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 2:2:1
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Olivier ADOTEVI, MD, Principal investigator, University Hospital of BesançonAntoine CARPENTIER, MD, Principal investigator, University Hospital of Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347210
- Sponsor's protocol ID
- 2024/894
- Other IDs
- 2024-514399-42-00
- Acronym
- MATVAC-1
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laheurte C, Boullerot L, Ndao B, Malfroy M, Queiroz L, Guillaume P, Loyon R, Seffar E, Gravelin E, Renaudin A, Jacquin M, Meurisse A, Vernerey D, Ghiringhelli F, Godet Y, Genolet R, Jandus C, Borg C, Adotevi O. UCPVax, a CD4 helper peptide vaccine, induces polyfunctional Th1 cells, antibody response, and epitope spreading to improve antitumor immunity. Cell Rep Med. 2025 Jul 15;6(7):102196. doi: 10.1016/j.xcrm.2025.102196. Epub 2025 Jun 20.
PubMed 40543509Adotevi O, Vernerey D, Jacoulet P, Meurisse A, Laheurte C, Almotlak H, Jacquin M, Kaulek V, Boullerot L, Malfroy M, Orillard E, Eberst G, Lagrange A, Favier L, Gainet-Brun M, Doucet L, Teixeira L, Ghrieb Z, Clairet AL, Guillaume Y, Kroemer M, Hocquet D, Moltenis M, Limat S, Quoix E, Mascaux C, Debieuvre D, Fagnoni-Legat C, Borg C, Westeel V. Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study. J Clin Oncol. 2023 Jan 10;41(2):373-384. doi: 10.1200/JCO.22.00096. Epub 2022 Sep 7.
PubMed 36070539
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma: a Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT07347210
- Acronym / sponsor ID
- MATVAC-1 / 2024/894
- Conditions
- Primary Glioblastoma
- Keywords
- GBM, UCPVax, pembrolizumab, cancer vaccine, telomerase, CD4 T cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- 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.
Glioblastomas (GBM) are the most frequent brain tumors and one of the most lethal adult cancers despite maximal multimodal therapy. Despite maximal safe resection followed by radiotherapy and temozolomide (TMZ) ± tumor-treating fields, median overall survival for newly diagnosed GBM remains around 18 months and long-term survival is rare, and recurrence is nearly universal. So, the development of new therapeutic strategies is a critical unmet need in GBM.
Despite the limited success of anti-PD(L)-1 therapy, immunotherapy remains a promising option in GBM. Current challenge supports to develop combinatorial therapy approaches considering the particular immune tumor microenvironment in GBM. Anticancer vaccines have shown promising signs of efficacy in GBM but critical factors challenge their efficacy. CD4 T help is of major interest for cancer vaccine effectiveness and for immune checkpoint inhibitors success. We previously designed UCPVax a CD4 T helper-targeted cancer vaccine derived from telomerase (TERT), a very attractive GBM-associated antigen (Adotévi O, J Clin Oncol 2023 ; Laheurte C, Cell Report Med 2025). The induction of robust tumor reactive CD4 T cell response with UCPVax together with TMZ-mediated immune effects will promote recruitment of effectors immune cells into tumor bed creating a more suitable microenvironment for anti-PD-1 action.
This is a proof-of-concept phase II trial to evaluate the efficacy of maintenance therapy evaluating UCPVax +/- pembrolizumab combined to standard treatment in newly diagnosed unmethylated MGMT glioblastoma. A translational research network will be implemented to better understand the therapeutic efficacy of this combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization 2:2:1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A | Experimental | Drug: UCPVax, Drug: Pembrolizumab, Drug: TemozolomideUCPVax + Pembrolizumab + Standard of care |
| Experimental Arm B | Experimental | Drug: UCPVax, Drug: TemozolomideUCPVax + Standard of care |
| Control Arm C | Other | Drug: TemozolomideStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female, age ≥ 18 with informed consent signed
- Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy).
- Tumor with unmethylated MGMT promoter status
- Patients having completed the concomitant phase of radiotherapy + temozolomide regimen (standard radiotherapy with 60 Gy in 30 fractions or hypofractionated radiotherapy with 40 Gy in 15 fractions), and eligible for the 6 monthly cycles of maintenance temozolomide
- Karnofsky Perfomance status (KPS) ≥ 70%
Key exclusion criteria (32 listed)
- IDH1 or IDH2 mutated tumor
- Presence of extracranial metastasis
- Leptomeningeal disease on MRI
- Contrast enhancement ≥4 cm (largest diameter on axial T1 sequences) on inclusion MRI
- Previous treatment with Carmustine impregnated wafers (GliadelR)
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 |
|---|---|---|
| UCPVaxPriming : UCPVax (two helper peptides UCP2 and UCP4 + Montanide ISA51) at 0.5 mg subcutaneously at day 1, 8, 15, 29, 36 and 43 Boost : UCPVax at 0.5 mg subcutaneously one month after priming and then every 8 weeks for 12 months maximum | Drug | Experimental Arm A, Experimental Arm B |
| Pembrolizumab400 mg/m1 every 6 weeks since day 1 until disease progression or unacceptable toxicity for a maximum of 1 year | Drug | Experimental Arm A |
| Temozolomide150-200 mg/m2/day x 5 days per month x 6 months according to best standard of care starting at day 1 of week 1 (with vaccine 1 of UCPVax). Additional treatment with NOVO-TTF200A will be allowed. | Drug | Control Arm C, Experimental Arm A, Experimental Arm B |
Primary outcome
Assessment of the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the experimental arm with UCPVax +/- pembrolizumab combined with standard treatment (Temozolomide +/- Novo-TTF-200A)
Time frame: 18 months
Rate for patients alive at 18 months post-randomization
8 secondary outcomes
Assessment of the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the control arm receiving standard treatment( Temozolomide +/- NovoTTF-200A)
Time frame: 18 months
Assessment of the Overall Survival (OS) in the three arms
Time frame: from date of randomization until date of death from any cause, assessed up to 42 months
Assessment of the progression free survival (PFS) since randomization in the three arms
Time frame: From date of randomization until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 42 months
Assessment of the progression free survival (PFS) at 6 months since randomization in the three arms
Time frame: 6 months
Evaluation of incidence of treatment-emergent adverse events in the three arms
Time frame: up to 42 months
Assessment of the immunogenicity of the proposal combination therapy.
Time frame: average of 30 months
Evaluation of health-related quality of life (HrQoL) in the two arms
Time frame: up to 42 months
Exploratory biomarker study
Time frame: average of 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 40543509Laheurte C, Boullerot L, Ndao B, Malfroy M, Queiroz L, Guillaume P, Loyon R, Seffar E, Gravelin E, Renaudin A, Jacquin M, Meurisse A, Vernerey D, Ghiringhelli F, Godet Y, Genolet R, Jandus C, Borg C, Adotevi O. UCPVax, a CD4 helper peptide vaccine, induces polyfunctional Th1 cells, antibody response, and epitope spreading to improve antitumor immunity. Cell Rep Med. 2025 Jul 15;6(7):102196. doi: 10.1016/j.xcrm.2025.102196. Epub 2025 Jun 20.
- Background: PubMed 36070539Adotevi O, Vernerey D, Jacoulet P, Meurisse A, Laheurte C, Almotlak H, Jacquin M, Kaulek V, Boullerot L, Malfroy M, Orillard E, Eberst G, Lagrange A, Favier L, Gainet-Brun M, Doucet L, Teixeira L, Ghrieb Z, Clairet AL, Guillaume Y, Kroemer M, Hocquet D, Moltenis M, Limat S, Quoix E, Mascaux C, Debieuvre D, Fagnoni-Legat C, Borg C, Westeel V. Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study. J Clin Oncol. 2023 Jan 10;41(2):373-384. doi: 10.1200/JCO.22.00096. Epub 2022 Sep 7.
- Individual participant dataSharing planned: No
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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.
Olivier ADOTEVI, MD principal investigator
University Hospital of Besançon
Antoine CARPENTIER, MD principal investigator
University Hospital of Besançon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UCPVax, Pembrolizumab and Temozolomide in people with Primary Glioblastoma, run by Centre Hospitalier Universitaire de Besancon at 4 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 17 inclusion and 32 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: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 Sophie DEPIERRE (+33 3 81 66 81 66, sdepierre@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the experimental arm with UCPVax +/- pembrolizumab combined with standard treatment (Temozolomide +/- Novo-TTF-200A) (time frame: 18 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 NCT07347210, 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 16 Jan 2026.