Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07341360

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital HF, Radium

Oslo, Oslo, Norway, 0379

Actively Recruiting

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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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