Recurrent Adult Brain TumorPhase 2NCT03890952
Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma
A Phase 2 study testing Nivolumab and Bevacizumab in people with Recurrent Adult Brain Tumor, run by Ulrik Lassen at 1 site in Denmark.
Trial summary
The aim of this study is to make preliminary assessment of PD-L1 and other immune related biomarkers that might act as predictors of anti-tumor activity of Nivolumab in patients with recurrent glioblastoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adult Brain Tumor
- What is being tested?
- Nivolumab and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed GBM (including all histologic variants);
- Age ≥ 18 years;
- Evidence of radiological (MRI-scan) measurable recurrent progressive GBM evaluated by the Response Assessment in Neuro-Oncology (RANO) criteria;
- In arm B measurable disease according to the RANO guidelines, within 14 days of starting treatment. Measurable disease after surgery on arm A is not required with radiographic evidence of recurrent disease after treatment with temozolomide and radiotherapy;
- An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrolment on this protocol;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
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- Life expectancy, in the opinion of the investigator > 3 month;
- Written informed consent obtained prior to any screening procedures. Patients must be willing and able to comply with the protocol and aware of the investigational nature of this study;
- Patients must have adequate bone marrow function and organ function within 2 weeks of study treatment as defined by the following laboratory criteria;
- Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 125,000/mm³; hemoglobin ≥ 9g/dL
- Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN) (excluding Gilberts Syndrome, for which bilirubin must be < 4 times ULN), ALAT < 2.5 times ULN;
- Renal function: serum creatinine < 1.5 ULN or estimated creatinine clearance of ≥ 50 mL/min, calculated using the formula of Cockcroft and Gault;
- APTT and INR < normal limit
- All female patients and partners of childbearing potential must agree to use adequate birth control during study treatment and for 5 months after the last dose of study drug and have a negative serum pregnancy test at screening. Acceptable methods of contraception are oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, or a sexual partner who is surgically sterilized or post-menopausal.
- Fertile males must be willing to employ adequate means of contraception during study treatment and for 7 months after the last dose of study drug;
- Archived paraffin-embedded tissue (approximately 10 unstained slides or a tumor block) must be available for confirmation of tumor diagnosis and correlative studies;
- Patients in the surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized recurrent tumor to allow for 500 mg of enhancing tumor and 300 mg of non-enhancing tumor to be resected;
- Patients must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to MRI and maximum of a dose of 20 mg prednisolone per day at enrollment of the study.
Who cannot join
- Patients must not have significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy;
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids (equivalent to max dose of 20 mg prednisolone per day) and stable for at least 5 days prior to day 1;
- Any condition (medical, social, psychological), which would prevent adequate information and follow-up;
- Any other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ;
- Uncontrolled hypertension (systolic blood pressure (BP) > 150 mmHg and/or diastolic BP > 100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment;
- Clinically significant peripheral vascular disease
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- Evidence of bleeding diathesis, coagulopathy or taking ASA, NSAIDs or clopidogrel;
- Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding);
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study;
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0;
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 0;
- Known active hepatitis A, B or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); hepatitis testing is not required;
- Known HIV infection; HIV testing is not required;
- Active infection requiring parenteral systemic antibiotics;
- Administration of a live, attenuated vaccine within 4 weeks before first dose of Nivolumab prior to surgery in Arm A or Cycle 1 Day 1 (Arm A and B) or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks before first dose of Nivolumab prior to surgery in Arm A or Cycle 1 Day 1 (Arm A and B) or at any time during the study;
- Severe infections within 4 weeks prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia;
- Received oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1 Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible;
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug;
- Dementia or altered mental status that would prohibit informed consent;
- History of organ allograft;
- History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner´s granulomatosis, Sjogren´s syndrome, Bell´s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis;
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted;
- Pregnant or breast-feeding women
- Prior treatment with PD-1/PD-L1 inhibitors
- Known hypersensitivity to any of the components of Nivolumab or Bevacizumab;
- Investigational therapy (defined as treatment for which there is no regulatory authority; within 28 days prior to Cycle 1 Day 1;
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to Cycle 1 Day 1, with the following exceptions:
- Hormone-replacement therapy or oral contraceptives
- Treatment with systemic immunosuppressive medications including, but not limited to: cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1, Day 1. The use of inhaled corticosteroids and mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
- Concurrent therapy with approved or investigational anticancer therapeutics;
- Body weight significantly below ideal body weight in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label, Two-armed Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma
The aim of this study is to make preliminary assessment of PD-L1 and other immune related biomarkers that might act as predictors of anti-tumor activity of Nivolumab in patients with recurrent glioblastoma
Read the detailed description
The effect of Nivolumab in oncologic diseases is to modulate the immune system in order to generate and/or restore a durable anti-tumor response leading to clearance of tumor. Clinical data generated with Nivolumab monotherapy in a variety of settings support the hypothesis that blockade of the PD-1 pathway results in rejection of tumor by the host immune system. The precise mechanisms by which Nivolumab exerts its anti-tumor activity are still under investigation. To contribute to this knowledge, tumor tissue from primary operation for all patients and tumor tissue from patients in the surgical Arm A will be used for further analysis.
Targeted sequencing with next generation sequencing (NGS) and Genome-wide Associations Studies (GWAS) with the use of single nucleotide polymorphism (SNP)-arrays and micro-array for expression profiling will be performed in order to describe the profile of the tumor. At Rigshospitalet has initiated a program of NGS of patients with GBM after informed content, by obtaining fresh tissue from primary or relapse surgery. In the surgical group (Arm A) of this study NGS will be repeated after one dose of Nivolumab. This information will be used in combination with the clinical observations for each patient receiving the combination of Nivolumab and Bevacizumab and the aim is that these results could be useful towards finding prognostic and/or predictive biomarkers in GBM.
In order to study the interaction between tumor cells and the immune system investigation of intratumoral and peripheral changes in tumor-infiltration lymphocytes (TILs) will be performed. By looking at TILs and peripheral blood lymphocytes (PBLs) Surgical samples will be compared to sequencing of baseline surgical samples (before Nivolumab). The interaction of TILs and tumor cells will be assessed with in vitro functional assays of autologous tumor cell recognition. Functional patterns of antitumor CD8+ and CD4+ TILs and PBLs will be investigated, with assays combining characterization of major T cell functions and simultaneous surface staining of PD-1 after co-culture with autologous tumor cells. This may detect treatment-induced changes in the functional repertoires of CD4+ and CD8+ TILs both in the tumor microenvironment (TILs) and in the periphery (PBLs). It is expected that these analyses will reveal whether significant functional changes (defined as increased frequency of tumor-reactive T cells or as functional shifting from a monofunctional to a multifunctional profile) are induced in the whole repertoire of T cells, or whether these changes are restricted to PD-1 positive T cells.
Regarding the immune-reactivity, CD8 T cell recognition of tumor-specific-antigens (TSA), i.e. and mutation derived neoepitopes will be analyzed in enrolled patients. To analyze for immune reactivity on a personalized basis by comprising epitope-maps based on both mutation-derived neoepitopes and shared tumor antigens selected based on the individual tumor mRNA expression level.
For the prediction of mutation- and splice-variation derived epitopes, whole exome sequencing (WES) and mRNA sequencing will be conducted on tumor versus germline-control samples. Cancer-specific mutations, indels, frameshifts and splice variations will be mapped to predict T cell epitopes overlapping these regions based on the patient HLA type, using available prediction tools, netMHC. A pipeline for processing next-generation sequencing data into tumor-specific neo-epitope maps has been generated to include analyses of tumor heterogeneity and generate personalized peptide libraries for each patient and analyze for T cell recognition of personalized neoepitopes in each patient included in the study. A novel technology will tag and track multiple (>1000) antigen specific T cell specificities based on their peptide-MHC (pMHC) recognition motif through a pMHC multimer with a co-attached 'DNA barcode'. Through use of this technology T cell recognition will be assessed against large libraries of peptides in limited biological samples, such as tissue biopsies, TILs and peripheral blood mononuclear cells (PBMCs). Data will reveal to what extend mutation and splice-variant derived neoepitopes are contributing to immune recognition as a consequence of checkpoint inhibition. If these are significantly recognized, then they are likely to play a crucial role for the clinical response to checkpoint inhibition.
- Conditions
- Recurrent Adult Brain Tumor
- Being tested
- Nivolumab, Bevacizumab
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Checkpoint inhibitor
Treatment with the combination of Nivolumab and bevacizumab every 2 weeks
BevacizumabDrug
Also called Angiogenesis inhibitor
Treatment with the combination of Nivolumab and bevacizumab every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm B Nivolumab and bevacizumab | Experimental | Nivolumab and bevacizumab in patients not undergoing salvage surgery Receives: Drug: Nivolumab; Drug: Bevacizumab |
| Arm A Nivolumab and bevacizumab | Experimental | Nivolumab and bevacizumab in patients undergoing salvage surgery Receives: Drug: Nivolumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of indels as determined using mRNA sequencing
whole exome sequencing (WES) and mRNA sequencing on tumor versus germline-control samples. We will map cancer-specific mutations, indels, frameshifts and splice variations, and predict T cell epitopes overlapping these regions based on the patient HLA type, using available prediction tools, netMHC
Measured: 8 weeks
Secondary outcomes (1)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) in both treatment Arms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Oct 2018
- Primary completion1 Feb 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms, non-randomized, not for comparison
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrik Lassen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen
- Responsible party
- Sponsor-investigator, Ulrik Lassen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrik Lassen, MD, PHD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890952
- Sponsor's protocol ID
- CA209-9UP
- Other IDs
- 2017-003925-13, 2017
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2019
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label, Two-armed Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03890952
- Acronym / sponsor ID
- CA209-9UP
- Conditions
- Recurrent Adult Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ulrik LassenUniversity, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 26 Mar 2019 (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.
The aim of this study is to make preliminary assessment of PD-L1 and other immune related biomarkers that might act as predictors of anti-tumor activity of Nivolumab in patients with recurrent glioblastoma
Detailed description
The effect of Nivolumab in oncologic diseases is to modulate the immune system in order to generate and/or restore a durable anti-tumor response leading to clearance of tumor. Clinical data generated with Nivolumab monotherapy in a variety of settings support the hypothesis that blockade of the PD-1 pathway results in rejection of tumor by the host immune system. The precise mechanisms by which Nivolumab exerts its anti-tumor activity are still under investigation. To contribute to this knowledge, tumor tissue from primary operation for all patients and tumor tissue from patients in the surgical Arm A will be used for further analysis.
Targeted sequencing with next generation sequencing (NGS) and Genome-wide Associations Studies (GWAS) with the use of single nucleotide polymorphism (SNP)-arrays and micro-array for expression profiling will be performed in order to describe the profile of the tumor. At Rigshospitalet has initiated a program of NGS of patients with GBM after informed content, by obtaining fresh tissue from primary or relapse surgery. In the surgical group (Arm A) of this study NGS will be repeated after one dose of Nivolumab. This information will be used in combination with the clinical observations for each patient receiving the combination of Nivolumab and Bevacizumab and the aim is that these results could be useful towards finding prognostic and/or predictive biomarkers in GBM.
In order to study the interaction between tumor cells and the immune system investigation of intratumoral and peripheral changes in tumor-infiltration lymphocytes (TILs) will be performed. By looking at TILs and peripheral blood lymphocytes (PBLs) Surgical samples will be compared to sequencing of baseline surgical samples (before Nivolumab). The interaction of TILs and tumor cells will be assessed with in vitro functional assays of autologous tumor cell recognition. Functional patterns of antitumor CD8+ and CD4+ TILs and PBLs will be investigated, with assays combining characterization of major T cell functions and simultaneous surface staining of PD-1 after co-culture with autologous tumor cells. This may detect treatment-induced changes in the functional repertoires of CD4+ and CD8+ TILs both in the tumor microenvironment (TILs) and in the periphery (PBLs). It is expected that these analyses will reveal whether significant functional changes (defined as increased frequency of tumor-reactive T cells or as functional shifting from a monofunctional to a multifunctional profile) are induced in the whole repertoire of T cells, or whether these changes are restricted to PD-1 positive T cells.
Regarding the immune-reactivity, CD8 T cell recognition of tumor-specific-antigens (TSA), i.e. and mutation derived neoepitopes will be analyzed in enrolled patients. To analyze for immune reactivity on a personalized basis by comprising epitope-maps based on both mutation-derived neoepitopes and shared tumor antigens selected based on the individual tumor mRNA expression level.
For the prediction of mutation- and splice-variation derived epitopes, whole exome sequencing (WES) and mRNA sequencing will be conducted on tumor versus germline-control samples. Cancer-specific mutations, indels, frameshifts and splice variations will be mapped to predict T cell epitopes overlapping these regions based on the patient HLA type, using available prediction tools, netMHC. A pipeline for processing next-generation sequencing data into tumor-specific neo-epitope maps has been generated to include analyses of tumor heterogeneity and generate personalized peptide libraries for each patient and analyze for T cell recognition of personalized neoepitopes in each patient included in the study. A novel technology will tag and track multiple (>1000) antigen specific T cell specificities based on their peptide-MHC (pMHC) recognition motif through a pMHC multimer with a co-attached 'DNA barcode'. Through use of this technology T cell recognition will be assessed against large libraries of peptides in limited biological samples, such as tissue biopsies, TILs and peripheral blood mononuclear cells (PBMCs). Data will reveal to what extend mutation and splice-variant derived neoepitopes are contributing to immune recognition as a consequence of checkpoint inhibition. If these are significantly recognized, then they are likely to play a crucial role for the clinical response to checkpoint inhibition.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel arms, non-randomized, not for comparison
| Arm | Type | Receives |
|---|---|---|
| Arm B Nivolumab and bevacizumab | Experimental | Drug: Nivolumab, Drug: BevacizumabNivolumab and bevacizumab in patients not undergoing salvage surgery |
| Arm A Nivolumab and bevacizumab | Experimental | Drug: Nivolumab, Drug: BevacizumabNivolumab and bevacizumab in patients undergoing salvage surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Pathologically confirmed GBM (including all histologic variants);
- Age ≥ 18 years;
- Evidence of radiological (MRI-scan) measurable recurrent progressive GBM evaluated by the Response Assessment in Neuro-Oncology (RANO) criteria;
- In arm B measurable disease according to the RANO guidelines, within 14 days of starting treatment. Measurable disease after surgery on arm A is not required with radiographic evidence of recurrent disease after treatment with temozolomide and radiotherapy;
- An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrolment on this protocol;
Key exclusion criteria (31 listed)
- Patients must not have significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy;
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids (equivalent to max dose of 20 mg prednisolone per day) and stable for at least 5 days prior to day 1;
- Any condition (medical, social, psychological), which would prevent adequate information and follow-up;
- Any other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ;
- Uncontrolled hypertension (systolic blood pressure (BP) > 150 mmHg and/or diastolic BP > 100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment;
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 |
|---|---|---|
| NivolumabAlso: Checkpoint inhibitorTreatment with the combination of Nivolumab and bevacizumab every 2 weeks | Drug | Arm A Nivolumab and bevacizumab, Arm B Nivolumab and bevacizumab |
| BevacizumabAlso: Angiogenesis inhibitorTreatment with the combination of Nivolumab and bevacizumab every 2 weeks | Drug | Arm A Nivolumab and bevacizumab, Arm B Nivolumab and bevacizumab |
Primary outcome
Number of indels as determined using mRNA sequencing
Time frame: 8 weeks
whole exome sequencing (WES) and mRNA sequencing on tumor versus germline-control samples. We will map cancer-specific mutations, indels, frameshifts and splice variations, and predict T cell epitopes overlapping these regions based on the patient HLA type, using available prediction tools, netMHC
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Lassen, MD, PHD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Bevacizumab in people with Recurrent Adult Brain Tumor, run by Ulrik Lassen at 1 site in Denmark.
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 18 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of indels as determined using mRNA sequencing (time frame: 8 weeks). 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 24 Jul 2025.