Pseudomyxoma PeritoneiEarly Phase 1PseudovaxNCT07341360
Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
A Early Phase 1 study testing Pseudovax, Molgramostim and Tislelizumab in people with Pseudomyxoma Peritonei, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Participants will receive vaccination with Pseudovax/GM-CSF in combination with PD-1 inhibitor tislelizumab over a period of up to two years. The vaccine is expected to reactivate measurable immune response, and tislelizumab to restore anticancer immunity in patients with GNAS mutated pseudomyxoma peritonei. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomyxoma Peritonei
- What is being tested?
- Pseudovax, Molgramostim and Tislelizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 13 Oct 2025to 31 Dec 2034
- Phase
- Early Phase 1
- 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
- The subject is ≥ 18 years of age on the day of signing the informed consent form, able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
- Confirmed diagnosis of recurrent or non-resectable PMP with no other available treatment options that are expected to be efficacious.
- The subject's tumor must carry a mutation in the GNAS oncogene*
- Subjects must have peritoneal tumor distribution at screening that, in the opinion of the Investigator, is suitable for repeat biopsies: Up to 3 biopsies of target tissue are planned for subjects that complete the study.
- Adequate organ, bone marrow, liver, and renal function at screening, including:
- Absolute neutrophil count: ≥ 1,5 x109/L
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- Platelets: ≥ 100 x109/L
- Hemoglobin: ≥ 9 x109/L
- Creatinine ≤ 1,5 upper limit normal (ULN) OR measured/calculated GFR ≥60 mL/min
- Albumin ≥ 30 g/L
- Total bilirubin ≤ 1,5 ULN
- ASAT and ALAT ≤ 3 ULN
- International Normalized Ratio (INR) ≤ 1,5 ULN and Activated Partial Thromboplastin Time (aPTT) ≤ 1,5 ULN unless subject is receiving anticoagulant therapy.
- ECOG performance status of 0 or 1.
- Life expectancy of >6 months, at the time of signing the informed consent.
- Women of childbearing potential must have a negative serum pregnancy test within 48 hours of the first study intervention, and must not be breast-feeding. 8ai. Female participant:
- Unless documented not to have childbearing potential: Subject is willing to use contraceptive measures for the duration of the study, and ≥ 6 months after the last dose of IMP, as prescribed by the protocol (according to the applicable guidance: CTFG, 2020). The Investigator should counsel women of childbearing potential of the importance of pregnancy prevention.
- 8aii. Women of childbearing potential must have a negative serum pregnancy test within 48 hours of the first study intervention.
- 8b. Male subject: Sexually active males must be willing to use a condom during sex for the duration of the study and for ≥ 6 months after the last dose of IMP. Males must also be willing to abstain from donating sperm during the same period.
Who cannot join
- Patient has Eastern Cooperative Oncology Group performance status 2 or worse.
- Blood transfusion or growth factor support ≤ 14 days before sample collection at screening.
- Active malignancy the past 3 years except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Enrollment in another interventional trial that, in the opinion of the Investigator, could influence the outcome of this study.
- Subject has within the last 30 days received any other interventional therapy that, in the opinion of the Investigator, could influence the outcome of this study.
- Pregnancy or lactating female.
Show all 26Show fewer
- Known active hepatitis B or C, or is known to be HIV-positive.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of IMP.
- Note: Subjects who are currently or have previously been on any of the following steroid regimens are not excluded: Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent); Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption; Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen).
- Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Subjects with the following diseases are not excluded and may proceed to further screening, controlled Type I diabetes, hypothyroidism (provided it is managed with hormone replacement therapy only), controlled celiac disease skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia), any other disease that is not expected to recur in the absence of external triggering factors.
- Diagnosis of immunodeficiency.
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- Severe infections within 4 weeks before first dose of IMP, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Therapeutic oral or intravenous antibiotics within 2 weeks before first dose of IMP.
- Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of IMP.
- Prior allogeneic stem cell transplantation or organ transplantation
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of IMP.
- Pulmonary embolism ≤ 28 days before first dose of IMP.
- History of acute myocardial infarction ≤ 6 months before first dose of IMP.
- History of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 6) ≤ 6 months before first dose of IMP.
- Subject has had any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of IMP.
- Severe hypersensitivity (≥grade 3) to chemotherapy, any other biologic drug or the contents or preservatives of any of the study drugs.
- History of cerebrovascular accident ≤ 6 months before first dose of IMP.
- Subject has underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital HF, Radium
Oslo, Oslo, 0379
Geir Olav Hjortland, Medical Doctor - Oncologist, +47 22934000, kreftstudier@ous-hf.no
Geir Olav Hjortland, Medical doctor - Oncologist
About this study
Official title: Pseudovav - A Cancer Vaccine Targeting Mutated GNAS Combined With Immune Checkpoint Inhibition for Patienes With Pseudomyxoma Peritonei
Participants will receive vaccination with Pseudovax/GM-CSF in combination with PD-1 inhibitor tislelizumab over a period of up to two years. The vaccine is expected to reactivate measurable immune response, and tislelizumab to restore anticancer immunity in patients with GNAS mutated pseudomyxoma peritonei.
Read the detailed description
Pseudomyxoma peritonei (PMP) is a rare, slow-growing abdominal cancer that commonly originates in ruptured appendiceal mucinous neoplasms, which seed tumor cells and mucin into the peritoneal cavity. The disease is characterized by slow, progressive growth and accumulation of mucinous tumor tissue in the peritoneal cavity, ultimately leading to abdominal compression and death. Standard-of-care treatment (SOC) involves extensive cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), and is curative in approximately 50% of the patients, but for patients who cannot be cured by SOC, no efficacious treatment options exist. In the setting of non-resectable and recurrent disease, PMP is a debilitating and ultimately fatal condition, leaving patients to experience progressively poor quality of life caused by an increasing intraperitoneal tumor burden. In research carried out by the study team, mutated GNAS as a potential tumor neo-antigen was investigated by analyzing tumor and peripheral blood samples collected from PMP patients at the time of surgery.
The results (detailed in the Pseudovax IB) indicated that the patients had a strong immune response against mutated GNAS. However, the presence of a high tumor burden at the time of surgery implies that the immune response had been insufficient to control tumor growth. Further analyses revealed that this could be explained by inhibition of anti-tumor T cells by up-regulation of immune checkpoint molecules.
These results provide the rationale for vaccination targeting mutated GNAS to increase the number of tumor cell targeting T cells. Furthermore, the observed up-regulation of programmed death-1 (PD-1) on intratumoral T cells provides rationale for combining the vaccination with a PD-1 inhibitor. Importantly, very few patients with PMP have had the opportunity to test treatment with immune checkpoint inhibitors. The main reason is that PMP molecularly is a microsatellite stable disease with very low tumor mutational burden, and patients are therefore not likely to respond to immune-check point inhibition (ICI) monotherapy. The planned combination with the Pseudovax peptide vaccine may represent a unique opportunity to derive benefit from ICI treatment for this patient group.
- Conditions
- Pseudomyxoma Peritonei
- Being tested
- Pseudovax, Molgramostim, Tislelizumab
- Keywords
- Pseudovax, PMP, Peptide vaccine, GNAS mutation, pseudomyxoma peritonei
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PseudovaxOther
Pseudovax peptide dissolved in 0.5 mL water for injection to 1 mg/mL (+/- 0.1 mg/mL)
MolgramostimBiological
Molgramostim, 100 μg recombinant human GM-CSF, powder, to be reconstituted in 0.33 mL water for injection
TislelizumabBiological
100 mg of humanized IgG4 mAb in 10 mL of isotonic solution
| Study group | Role | What they receive |
|---|---|---|
| Pseudovax peptide, adjuvant and PD-1 inhibitor | Experimental | Participants will be administered the Pseudovax peptide vaccine + adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF). From study week 13, the programmed cell death 1 (PD-1) inhibitor tislelizumab will be administered in addition, for a maximum of 21 months, until confirmed progression, unacceptable toxicity, withdrawal of consent, or Investigator decision, whichever happens first. Receives: Other: Pseudovax; Biological: Molgramostim; Biological: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of sequential treatment with Pseudovax/GM-CSF and tislelizumab
Incidence of Investigative Medicinal Product-related adverse events. All ≥ Grade 3 adverse events and all grades vaccine-related adverse events will be reported and graded using CTCAE v 5.0.
Measured: From start treatment to 6 months after last dose of study drug.
Immune responses following sequential treatment with Pseudovax/GM-CSF and tislelizumab
Count of circulating vaccine-specific T cells
Measured: From enrollment to end of treatment (2 years).
Secondary outcomes (1)
Progression-free survival, measured as the number of months from date of first treatment until disease progression or death from any cause
Assessment of preliminary efficacy of study treatment with Pseudovax/GM-CSF and Tislelizumab, measured as the number of months from date of first treatment until disease progression or death from any cause
Measured: From start treatment to disease progression, death or last follow-up 6 months after last dose of study drug (whichever comes first).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start13 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Design: A phase 1, first-in-human open label, single-arm trial, combining the novel peptide vaccine Pseudovax against mutated GNAS (Gsα) with adjuvant granulocyte macrophage - colony stimulating factor (GM-CSF) and subsequent treatment with the immune checkpoint inhibitor tislelizumab (anti-PD-1) in adult subjects with recurrent or non-resectable GNAS-mutated pseudomyxoma peritonei (PMP). Study treatment: Participants will be administered the Pseudovax peptide vaccine + adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF). From study week 13, the programmed cell death 1 (PD-1) inhibitor tislelizumab will be administered in addition, for a maximum of 21 months, until confirmed progression, unacceptable toxicity, withdrawal of consent, or Investigator decision, whichever happens first.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Principal investigator, Geir Olav Hjortland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341360
- Sponsor's protocol ID
- 2024-517047-30-01
- Other IDs
- 2024-517047-30-01
- Acronym
- Pseudovax
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By now there is no plan on sharing IPD as the patient group is very small (ten patients plan) with a rare disease. As a result we can not make this data widely available without violating GDPR guidance. For researchers interested in the data, a request can be send to the study team.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudovav - A Cancer Vaccine Targeting Mutated GNAS Combined With Immune Checkpoint Inhibition for Patienes With Pseudomyxoma Peritonei
- ClinicalTrials.gov ID
- NCT07341360
- Acronym / sponsor ID
- Pseudovax / 2024-517047-30-01
- Conditions
- Pseudomyxoma Peritonei
- Keywords
- Pseudovax, PMP, Peptide vaccine, GNAS mutation, pseudomyxoma peritonei
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 14 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.
Participants will receive vaccination with Pseudovax/GM-CSF in combination with PD-1 inhibitor tislelizumab over a period of up to two years. The vaccine is expected to reactivate measurable immune response, and tislelizumab to restore anticancer immunity in patients with GNAS mutated pseudomyxoma peritonei.
Detailed description
Pseudomyxoma peritonei (PMP) is a rare, slow-growing abdominal cancer that commonly originates in ruptured appendiceal mucinous neoplasms, which seed tumor cells and mucin into the peritoneal cavity. The disease is characterized by slow, progressive growth and accumulation of mucinous tumor tissue in the peritoneal cavity, ultimately leading to abdominal compression and death. Standard-of-care treatment (SOC) involves extensive cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), and is curative in approximately 50% of the patients, but for patients who cannot be cured by SOC, no efficacious treatment options exist. In the setting of non-resectable and recurrent disease, PMP is a debilitating and ultimately fatal condition, leaving patients to experience progressively poor quality of life caused by an increasing intraperitoneal tumor burden. In research carried out by the study team, mutated GNAS as a potential tumor neo-antigen was investigated by analyzing tumor and peripheral blood samples collected from PMP patients at the time of surgery.
The results (detailed in the Pseudovax IB) indicated that the patients had a strong immune response against mutated GNAS. However, the presence of a high tumor burden at the time of surgery implies that the immune response had been insufficient to control tumor growth. Further analyses revealed that this could be explained by inhibition of anti-tumor T cells by up-regulation of immune checkpoint molecules.
These results provide the rationale for vaccination targeting mutated GNAS to increase the number of tumor cell targeting T cells. Furthermore, the observed up-regulation of programmed death-1 (PD-1) on intratumoral T cells provides rationale for combining the vaccination with a PD-1 inhibitor. Importantly, very few patients with PMP have had the opportunity to test treatment with immune checkpoint inhibitors. The main reason is that PMP molecularly is a microsatellite stable disease with very low tumor mutational burden, and patients are therefore not likely to respond to immune-check point inhibition (ICI) monotherapy. The planned combination with the Pseudovax peptide vaccine may represent a unique opportunity to derive benefit from ICI treatment for this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Design: A phase 1, first-in-human open label, single-arm trial, combining the novel peptide vaccine Pseudovax against mutated GNAS (Gsα) with adjuvant granulocyte macrophage - colony stimulating factor (GM-CSF) and subsequent treatment with the immune checkpoint inhibitor tislelizumab (anti-PD-1) in adult subjects with recurrent or non-resectable GNAS-mutated pseudomyxoma peritonei (PMP). Study treatment: Participants will be administered the Pseudovax peptide vaccine + adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF). From study week 13, the programmed cell death 1 (PD-1) inhibitor tislelizumab will be administered in addition, for a maximum of 21 months, until confirmed progression, unacceptable toxicity, withdrawal of consent, or Investigator decision, whichever happens first.
| Arm | Type | Receives |
|---|---|---|
| Pseudovax peptide, adjuvant and PD-1 inhibitor | Experimental | Other: Pseudovax, Biological: Molgramostim, Biological: TislelizumabParticipants will be administered the Pseudovax peptide vaccine + adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF). From study week 13, the programmed cell death 1 (PD-1) inhibitor tislelizumab will be administered in addition, for a maximum of 21 months, until confirmed progression, unacceptable toxicity, withdrawal of consent, or Investigator decision, whichever happens first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The subject is ≥ 18 years of age on the day of signing the informed consent form, able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
- Confirmed diagnosis of recurrent or non-resectable PMP with no other available treatment options that are expected to be efficacious.
- The subject's tumor must carry a mutation in the GNAS oncogene*
- Subjects must have peritoneal tumor distribution at screening that, in the opinion of the Investigator, is suitable for repeat biopsies: Up to 3 biopsies of target tissue are planned for subjects that complete the study.
- Adequate organ, bone marrow, liver, and renal function at screening, including:
Key exclusion criteria (26 listed)
- Patient has Eastern Cooperative Oncology Group performance status 2 or worse.
- Blood transfusion or growth factor support ≤ 14 days before sample collection at screening.
- Active malignancy the past 3 years except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Enrollment in another interventional trial that, in the opinion of the Investigator, could influence the outcome of this study.
- Subject has within the last 30 days received any other interventional therapy that, in the opinion of the Investigator, could influence the outcome of this study.
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 |
|---|---|---|
| PseudovaxPseudovax peptide dissolved in 0.5 mL water for injection to 1 mg/mL (+/- 0.1 mg/mL) | Other | Pseudovax peptide, adjuvant and PD-1 inhibitor |
| MolgramostimMolgramostim, 100 μg recombinant human GM-CSF, powder, to be reconstituted in 0.33 mL water for injection | Biological | Pseudovax peptide, adjuvant and PD-1 inhibitor |
| Tislelizumab100 mg of humanized IgG4 mAb in 10 mL of isotonic solution | Biological | Pseudovax peptide, adjuvant and PD-1 inhibitor |
Primary outcome
Safety and tolerability of sequential treatment with Pseudovax/GM-CSF and tislelizumab
Time frame: From start treatment to 6 months after last dose of study drug.
Incidence of Investigative Medicinal Product-related adverse events. All ≥ Grade 3 adverse events and all grades vaccine-related adverse events will be reported and graded using CTCAE v 5.0.
Immune responses following sequential treatment with Pseudovax/GM-CSF and tislelizumab
Time frame: From enrollment to end of treatment (2 years).
Count of circulating vaccine-specific T cells
1 secondary outcome
Progression-free survival, measured as the number of months from date of first treatment until disease progression or death from any cause
Time frame: From start treatment to disease progression, death or last follow-up 6 months after last dose of study drug (whichever comes first).
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 14 Jan 2026.
- Individual participant dataSharing planned: No. By now there is no plan on sharing IPD as the patient group is very small (ten patients plan) with a rare disease. As a result we can not make this data widely available without violating GDPR guidance. For researchers interested in the data, a request can be send to the study team.
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Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum
RecruitingObservational study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pseudovax, Molgramostim and Tislelizumab in people with Pseudomyxoma Peritonei, run by Oslo University Hospital at 1 site in Norway.
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 19 inclusion and 26 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 14 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 1 site in Norway. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Geir Olav Hjortland, Medical Doctor - Oncologist (+47 22934000, kreftstudier@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of sequential treatment with Pseudovax/GM-CSF and tislelizumab (time frame: From start treatment to 6 months after last dose of study drug.). 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 14 Jan 2026.