Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei (NCT07341360) | Clinical Trial Compass
RecruitingEarly Phase 1
Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
Norway10 participantsStarted 2025-10-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of sequential treatment with Pseudovax/GM-CSF and tislelizumab
Timeframe: From start treatment to 6 months after last dose of study drug.
2
Immune responses following sequential treatment with Pseudovax/GM-CSF and tislelizumab
Timeframe: From enrollment to end of treatment (2 years).
. 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.
. 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.