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 range18 Years
SexALL
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Inclusion criteria
ā. The subject is ā„ 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.
ā. Confirmed diagnosis of recurrent or non-resectable PMP with no other available treatment options that are expected to be efficacious.
ā. The subject's tumor must carry a mutation in the GNAS oncogene\*
ā. 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.
ā. Adequate organ, bone marrow, liver, and renal function at screening, including:
ā. Absolute neutrophil count: ā„ 1,5 x109/L
ā. Platelets: ā„ 100 x109/L
ā. Hemoglobin: ā„ 9 x109/L
Exclusion criteria
ā. Patient has Eastern Cooperative Oncology Group performance status 2 or worse.
ā. Blood transfusion or growth factor support ā¤ 14 days before sample collection at screening.
ā. 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)
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).
ā. Enrollment in another interventional trial that, in the opinion of the Investigator, could influence the outcome of this study.
ā. 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.
ā. Pregnancy or lactating female.
ā. Known active hepatitis B or C, or is known to be HIV-positive.
ā. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ā¤ 14 days before the first dose of IMP.