Newly Diagnosed GlioblastomaPhase 1/2NAVIG-1NCT06622434
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
A Phase 1/2 study testing immunization in people with Newly Diagnosed Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
This phase I/II trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas. The objectives of this study are as follows: Primary objective phase 1: to assess the maximum tolerated dose (MTD) and select the recommend Phase 2a dose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Newly Diagnosed Glioblastoma
- What is being tested?
- immunization
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Nov 2024to 8 Mar 2028
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years old
- free, informed and written consent signed
- Histologically confirmed glioblastoma
- Patients previously treated with concurrent radiotherapy (at least 45 Gy) with concomitant temozolomide, before the beginning of the 6 additional monthly cycles of temozolomide. Radiation therapy must have been completed 28 to 45 days prior to the first study treatment
- Karnofsky Performance Status ≥ 60%
- Phase 1 only: Patients must be human leukocyte antigen (HLA)-A2 positive.
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- Phase 1 only: PTPRZ1 expression in the tumor
- Available tumor tissue for post hoc (retrospective) assessment of TERT promoter mutations and MGMT promoter methylation status
- Life expectancy ≥ 3 months
- Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
- Women or Male of childbearing potential (WOCBP) must use contraceptive methods during and for 180 days after the last dose of temozolomide or up to 120 days after the last dose of vaccine, whichever is longer (see section 6.3). No sperm donation during the study and until 7 months after the end of the treatment period.
- Patient affiliated to the social security scheme
Who cannot join
- Known extracranial metastatic or leptomeningeal disease
- Grade 4 astrocytoma IDH mutant
- Steroid requirement >10 mg prednisone daily (or equivalent) at time of inclusion
- Patients with prior malignancy active within the last 3 years
- Patients receiving immunomodulatory or immunosuppressive therapy
- Carmustine wafers (GliadelR) implantation during surgery
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- Phase 1 only: patient eligible and willing to be treated with Optune (TTF fields)
- History of autoimmune disease (lupus, rheumatoid arthritis, inflammatory bowel disease...)
- 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.
- 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
- Breast-feeding or pregnant women.
- Contra-indications to IRM
- Contra-indications to investigational medicinal product and/or to auxiliary medicinal products
- Participation to another interventional clinical trial, clinical investigation or another interventional study or being in the exclusion period at the end of a previous study
- Patient unable to follow the procedures and constraints of the protocol
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Neuro-oncology Department, La Timone Hospital
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
Emeline TABOURET, Pr, +33491385500, Emeline.TABOURET@ap-hm.fr
- Recruiting
Department of Neurology, Hopital de la Salpêtrière
Paris, Idf, 75013
Ahmed IDBAIH, Pr, +3342160381, Ahmed.idbaih@aphp.fr
- Recruiting
Department of Neurology, Hopital Saint louis (APHP)
Paris, 75010
Antoine CARPENTIER, Pr, +331712074066, Antoine.carpentier@aphp.fr
About this study
Official title: New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NAVIG-1)
This phase I/II trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas.
The objectives of this study are as follows:
Read more
Primary objective
- phase 1:
- to assess the maximum tolerated dose (MTD) and select the recommend Phase 2a dose
- phase 2a:
- to assess anti- TERT specific T cell responses at 2 months at the selected dose level
Secondary objectives:
- To assess Short and long-time immunological safety
- To assess Evolution of anti-PTPRZ1 and anti-TERT immune T cell responses over time
- To assess Progression free survival (RANO 2.0 criteria)
- To assess Overall survival
- To assess Quality of life by EORTC QLQ30 and BN20 questionnaires
- To evaluate cardiac safety and monitor for the potential development of anti-melanin antibodies in a cohort of 8 patients enrolled in the Phase 2a study as well as objective of ancillary study: to determine the mechanism of action of potential tumour escape in GBM (T-cell lymphocyte phenotype; antigen expression and checkpoint inhibitors on tumour cells at relapse, if available), analysis of circulating antibodies against TERT epitope and/or melanin, and identification of predictive biomarkers of response.
Ultimately, this trial together will lead to the implementation of future phase III trial in GBM.
All patients enrolled in the study will receive standard treatment consisting of surgical resection of the tumor followed by radio-chemotherapy. Immunotherapy will begin 4 weeks after the completion of radiotherapy.
Read the detailed description
Prospective multicentre Phase I- IIa, non-comparative, non-randomised study with escalating doses for the Phase 1 part.
Therapeutic cancer vaccines consisting of 1 or 2 antigenic peptidic formulations combined with an immune adjuvant:
- A52-Mel: a TERT peptidic epitope adsorbed on synthetic melanin
- A49-Mel: a PTPRZ1 peptidic epitope adsorbed on synthetic melanin (Phase 1 only)
- Litenimod, a TLR9 agonist, as an adjuvant
Phase 1: Patients will receive subcutaneous injections in the shoulders of both A49 and A52 at one of 3 pre-specified dose levels of peptides (50-100-250µg) + 1mg of Litenimod (fixed dose).
Phase 2a: Patients will receive subcutaneous injections in the shoulder of A52 only at the dose selected in the phase 1 part + 1mg of Litenimod
- Conditions
- Newly Diagnosed Glioblastoma
- Being tested
- immunization
- Keywords
- Cancer vaccine, Glioblastoma, Telomerase, TERT, PTPRZ1, Immunomodulation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunizationBiological
One month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide (5 days per month for 6 months). Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months until progression, unacceptable toxicity, withdrawal of consent, or study end (at 12 months), whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| A52-Mel; A49-Mel (for Phase1 only) and Litenimod, as an adjuvant | Experimental | In Phase 1, A52-Mel and A49-Mel will be mixed just prior to the injection. Litenimod will be injected at the same site just after the injection.
In phase 2a, A52-Mel was initially administered as a standalone injection, followed by Litenimod at the same injection site. Then, an optimized procedure allows the injection of A52-Mel and Litenimod simultaneously, the two components being mixed extemporaneously prior to the injection. Receives: Biological: immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) for Phase 1
the maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT)
Measured: 2 months
anti-TERT specific T cell responses (safety/efficay) for Phase 2
anti-TERT specific T cell responses by using IFN-gamma ELISPOT
Measured: 2 months
Secondary outcomes (6)
Evolution of anti-PTPRZ1 specific T cell responses
anti-PTPRZ1 specific T cell responses by using IFN-gamma ELISPOT
Measured: over time
Overall survival
The time interval from the start of treatment to the date of death from any cause.
Measured: 12 months
Progression free survival
Tumor response will be assessed using RANO 2.0 criteria
Measured: 12 months
the evaluation of quality of life
EORTC-QLQC30 questionnaire and BN20 module will be completed by each patient (Not all= 1; A little=2; Quite a bit= 3 ; Very Much=4)
Measured: 5 months
Circulating anti-melanin antibodies
in a cohort of 8 patients enrolled in the Phase 2a study
Measured: At M2
Cardiac safety
evaluated through 12-lead ECG assessments prior to injection, 3 hours post-injection, Day 7, Week 2, and Month 2), with a focus on QT-interval measurement. Additionally, cardiac biomarkers including troponin and pro-BNP will be monitored at baseline (Day 0), Week 2, and Month 2.
assessed using 12-lead ECGs performed 3 hours after injection, on day 7, at week 2 and at
Measured: At month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start8 Nov 2024
- Primary completion8 Mar 2028 (estimated)
- Study completion8 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ALTEVAX SAS
- Responsible party
- Sponsor
- Investigators
- Antoine CARPENTIER, Pr, Study chair, APHP- Hôpital Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622434
- Sponsor's protocol ID
- APHP240512
- Other IDs
- 2024-514567-26-00
- Acronym
- NAVIG-1
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NAVIG-1)
- ClinicalTrials.gov ID
- NCT06622434
- Acronym / sponsor ID
- NAVIG-1 / APHP240512
- Conditions
- Newly Diagnosed Glioblastoma
- Keywords
- Cancer vaccine, Glioblastoma, Telomerase, TERT, PTPRZ1, Immunomodulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ALTEVAX SAS
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 8 Mar 2028 (estimated)
- Study completion
- 8 Mar 2028 (estimated)
- First posted
- 2 Oct 2024 (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.
This phase I/II trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas.
The objectives of this study are as follows:
Primary objective
- phase 1:
- to assess the maximum tolerated dose (MTD) and select the recommend Phase 2a dose
- phase 2a:
- to assess anti- TERT specific T cell responses at 2 months at the selected dose level
Secondary objectives:
- To assess Short and long-time immunological safety
- To assess Evolution of anti-PTPRZ1 and anti-TERT immune T cell responses over time
- To assess Progression free survival (RANO 2.0 criteria)
- To assess Overall survival
- To assess Quality of life by EORTC QLQ30 and BN20 questionnaires
- To evaluate cardiac safety and monitor for the potential development of anti-melanin antibodies in a cohort of 8 patients enrolled in the Phase 2a study as well as objective of ancillary study: to determine the mechanism of action of potential tumour escape in GBM (T-cell lymphocyte phenotype; antigen expression and checkpoint inhibitors on tumour cells at relapse, if available), analysis of circulating antibodies against TERT epitope and/or melanin, and identification of predictive biomarkers of response.
Ultimately, this trial together will lead to the implementation of future phase III trial in GBM.
All patients enrolled in the study will receive standard treatment consisting of surgical resection of the tumor followed by radio-chemotherapy. Immunotherapy will begin 4 weeks after the completion of radiotherapy.
Detailed description
Prospective multicentre Phase I- IIa, non-comparative, non-randomised study with escalating doses for the Phase 1 part.
Therapeutic cancer vaccines consisting of 1 or 2 antigenic peptidic formulations combined with an immune adjuvant:
- A52-Mel: a TERT peptidic epitope adsorbed on synthetic melanin
- A49-Mel: a PTPRZ1 peptidic epitope adsorbed on synthetic melanin (Phase 1 only)
- Litenimod, a TLR9 agonist, as an adjuvant
Phase 1: Patients will receive subcutaneous injections in the shoulders of both A49 and A52 at one of 3 pre-specified dose levels of peptides (50-100-250µg) + 1mg of Litenimod (fixed dose).
Phase 2a: Patients will receive subcutaneous injections in the shoulder of A52 only at the dose selected in the phase 1 part + 1mg of Litenimod
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A52-Mel; A49-Mel (for Phase1 only) and Litenimod, as an adjuvant | Experimental | Biological: immunizationIn Phase 1, A52-Mel and A49-Mel will be mixed just prior to the injection. Litenimod will be injected at the same site just after the injection. In phase 2a, A52-Mel was initially administered as a standalone injection, followed by Litenimod at the same injection site. Then, an optimized procedure allows the injection of A52-Mel and Litenimod simultaneously, the two components being mixed extemporaneously prior to the injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age between 18 and 75 years old
- free, informed and written consent signed
- Histologically confirmed glioblastoma
- Patients previously treated with concurrent radiotherapy (at least 45 Gy) with concomitant temozolomide, before the beginning of the 6 additional monthly cycles of temozolomide. Radiation therapy must have been completed 28 to 45 days prior to the first study treatment
- Karnofsky Performance Status ≥ 60%
Key exclusion criteria (17 listed)
- Known extracranial metastatic or leptomeningeal disease
- Grade 4 astrocytoma IDH mutant
- Steroid requirement >10 mg prednisone daily (or equivalent) at time of inclusion
- Patients with prior malignancy active within the last 3 years
- Patients receiving immunomodulatory or immunosuppressive therapy
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 |
|---|---|---|
| immunizationOne month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide (5 days per month for 6 months). Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months until progression, unacceptable toxicity, withdrawal of consent, or study end (at 12 months), whichever occurs first. | Biological | A52-Mel; A49-Mel (for Phase1 only) and Litenimod, as an adjuvant |
Primary outcome
Maximum tolerated dose (MTD) for Phase 1
Time frame: 2 months
the maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT)
anti-TERT specific T cell responses (safety/efficay) for Phase 2
Time frame: 2 months
anti-TERT specific T cell responses by using IFN-gamma ELISPOT
6 secondary outcomes
Evolution of anti-PTPRZ1 specific T cell responses
Time frame: over time
Overall survival
Time frame: 12 months
Progression free survival
Time frame: 12 months
the evaluation of quality of life
Time frame: 5 months
Circulating anti-melanin antibodies
Time frame: At M2
Cardiac safety
Time frame: At month 2
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 11 Jun 2026.
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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.
Antoine CARPENTIER, Pr study chair
APHP- Hôpital Saint Louis
3 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 immunization in people with Newly Diagnosed Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 3 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 12 inclusion and 17 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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?
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 Antoine CARPENTIER, Pr (0171207466, antoine.carpentier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) for Phase 1 (time frame: 2 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?
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 11 Jun 2026.