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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pseudovax
Other interventionPseudovax peptide dissolved in 0.5 mL water for injection to 1 mg/mL (+/- 0.1 mg/mL)
Molgramostim
Biological/VaccineMolgramostim, 100 μg recombinant human GM-CSF, powder, to be reconstituted in 0.33 mL water for injection
Tislelizumab
Biological/Vaccine100 mg of humanized IgG4 mAb in 10 mL of isotonic solution
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Pseudovax peptide, adjuvant and PD-1 inhibitorExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety and tolerability of sequential treatment with Pseudovax/GM-CSF and tislelizumab
Incidence of Investigative Medicinal Product-related adverse events. All ≥ Grade 3 adverse events and all grades vaccine-related adverse events will be reported and graded using CTCAE v 5.0.
Time frame
From start treatment to 6 months after last dose of study drug.2
Immune responses following sequential treatment with Pseudovax/GM-CSF and tislelizumab
Count of circulating vaccine-specific T cells
Time frame
From enrollment to end of treatment (2 years).Secondary outcomes
1
Progression-free survival, measured as the number of months from date of first treatment until disease progression or death from any cause
Assessment of preliminary efficacy of study treatment with Pseudovax/GM-CSF and Tislelizumab, measured as the number of months from date of first treatment until disease progression or death from any cause
Time frame
From start treatment to disease progression, death or last follow-up 6 months after last dose of study drug (whichever comes first).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
BeiGene
Collaborator
Source ClinicalTrials.gov