Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
ConditionPseudomyxoma Peritonei
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pseudovax
- Molgramostim
- Tislelizumab
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Oslo University Hospital
Lead sponsor
BeiGene
Collaborator
Source ClinicalTrials.gov