Actively Recruiting
Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
Led by Oslo University Hospital · Updated on 2026-01-14
10
Participants Needed
1
Research Sites
480 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to provide written informed consent
- Confirmed diagnosis of recurrent or non-resectable pseudomyxoma peritonei with no effective treatment options
- Tumor must have a mutation in the GNAS oncogene
- Peritoneal tumor distribution suitable for up to 3 repeat biopsies
- Adequate organ, bone marrow, liver, and kidney function based on laboratory values
- ECOG performance status of 0 or 1
- Life expectancy longer than 6 months
- Women of childbearing potential must have a negative pregnancy test within 48 hours before first study treatment and agree to use contraception during and 6 months after treatment
- Male participants who are sexually active must use condoms during the study and for 6 months after, and not donate sperm during this period
You will not qualify if you...
- ECOG performance status of 2 or worse
- Blood transfusion or growth factor support within 14 days before screening
- Active cancers within the past 3 years except for the study cancer or certain treated local cancers
- Participation in another interventional trial that could affect this study
- Other interventional therapy within 30 days before this study
- Pregnant or breastfeeding females
- Known active hepatitis B or C infection or HIV-positive status
- Recent systemic corticosteroid or immunosuppressive treatment within 14 days before first dose
- Active or history of autoimmune diseases that may relapse, except certain controlled conditions
- Diagnosis of immunodeficiency
- History of certain lung diseases or uncontrolled pulmonary conditions
- Severe infections requiring systemic treatment recently or within 4 weeks before first dose
- Use of therapeutic antibiotics within 2 weeks before first dose
- Major surgery requiring general anesthesia within 28 days before first dose
- Prior allogeneic stem cell or organ transplantation
- Recent cardiac events including chest pain, pulmonary embolism, myocardial infarction, or heart failure within specified recent periods
- Severe allergic reactions to chemotherapy, biologics, or study drug components
- History of stroke within 6 months
- Unfavorable medical conditions or substance abuse affecting treatment or study compliance
- Any other reason the investigator believes the patient should not participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oslo University Hospital HF, Radium
Oslo, Oslo, Norway, 0379
Actively Recruiting
Research Team
G
Geir Olav Hjortland, Medical Doctor - Oncologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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